Non-invasive and minimally invasive and tightly targeted minimally invasive therapy methods and devices for parathyroid treatment

ABSTRACT

Systems and method for treating organic tissue of a patient&#39;s body in precisely controlled regions of the body such as the parathyroid glands. The systems and methods include introducing an energy or substance into contact with target tissue to control functionality of the target tissue and preventing the energy or substance from contacting surrounding non-target tissues sufficiently that functionality of critical non-target tissues is substantially not affected.

PRIORITY CLAIM

This application claims the benefit of U.S. Provisional Application No.61/538,708 filed on Sep. 23, 2011, the subject matter of which isincorporated herein by reference in its entirety.

COPYRIGHT NOTICE

A portion of this patent document contains material that is subject tocopyright protection. The copyright owner does not object to thefacsimile reproduction of the patent document as it appears in the U.S.Patent and Trademark Office patent file or records but otherwisereserves all copyright rights whatsoever.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, methods andsystems, and in particular for the treatment of parathyroid glands andparathyroid-based diseases, such as hyperparathyroidism,hypoparathyroidism and hypercalcemia

BACKGROUND OF THE INVENTION

In the human body there are four small parathyroid glands. Each glandtypically weighs about thirty 30 to forty 40 mg and is located near thethyroid. The cells of the parathyroid glands release parathyroidhormone, which helps maintain serum and bone calcium homeostasis in thebody. The two upper parathyroid glands are usually located adjacent tothe posterior surface of the upper or middle part, of the thyroid lobe,just anterior to the recurrent laryngeal nerve as it enters the larynx.The two lower parathyroid glands are usually found on the lateral orposterior surfaces of the lower part of the thyroid gland or withinseveral centimeters of the lower thyroid pole.

The thyroid gland generally receives innervations from both thesympathetic and parasympathetic divisions of the autonomic nervoussystem. The sympathetic fibers arise from the cervical ganglia and enterwith blood vessels and the parasympathetic fibers arise from the vagusand reach the thyroid gland via branches of the laryngeal nerves. Theparathyroid and thyroid glands relation to the recurrent laryngealnerves and to the external branch of the superior laryngeal nerves is ofmajor surgical significance because damage to these nerves can lead to adisability of phonation. Based on the close anatomic association of thethyroid and parathyroid glands, it is assumed that the parathyroids areinnervated in a manner similar to that of the thyroid.

Disorders of the parathyroid gland include hyperparathyroidism,hypoparathyroidism, osteoporoses, as well as a myriad of other diseases.Primary hyperparathyroidism exists when a disorder of parathyroid tissueitself, or a “primary defect,” results in the release of excessiveamounts of Parathyroid hormone. Among the known causes of primaryhyperparathyroidism, as well as examples of primary defects, areparathyroid adenoma, hyperplasia and carcinoma. Parathyroid adenomas andhyperplasia and carcinomas can all overproduce parathyroid hormone orprecursors or active components of the parathyroid hormone. Secondaryhyperparathyroidism is usually a reactive parathyroid hyperplasicphenomenon accompanying renal failure. Symptoms of secondaryhyperparathyroidism can include nephrolithiasis, bone disease, pepticulcer, fatigue, muscle aches, depression and hypertension. Untreatedhyperparathyroidism can result in loss of bone mass due to hypercalcemiaresulting from excessive levels of circulating Parathyroid. A high levelof Parathyroid causes unbalanced osteoclastic bone reabsorption that canlead to multiple foci of bone destruction, osteitis fibrosa cystica, orvon Recklinghausen's disease of bone. Excess parathyroid hormone is oneof the leading causes of osteoporosis and it is a primary cause ofkidney stones.

Current treatment for primary hyperparathyroidism generally involvessurgical removal or resection of all or part of the abnormal parathyroidtissue. However, parathyroid surgery (parathryoidectomy) requiresexceptional skill because the parathyroid glands are notoriouslyvariable in location and intimate knowledge of the intrathroidal,retroesophageal, lateral neck, and mediastinum anatomy is required.Accordingly, a number of preoperative tests are usually performed tobetter define the position of the abnormal gland or glands, includingbut not limited to: thallium-technetium subtraction scans, ultrasound,selective venous sampling, computed tomography (CT), magnetic resonanceimaging (MRI), scintigraphy with technetium-99m sestamibi (sestamibiscanning), and arteriography. Despite this, many parathyroidectomiesfail due to failure to localize the parathyroid on diagnositicexaminations or because of surgical failure to identify and remove thedysfunctional parathyroid gland. Other complications and attendant risksof surgical treatment of hyperparathyroidism include excessive removalof parathyroid glands tissue, hematoma, vocal cord paralysis,hypocalcemia, and persistent hypercalcemia. Moreover, conventionalsurgical techniques typically do not allow for the accurate partialremoval of abnormal parathyroid glands, thus, even when single glandulardisease is involved, a multiple glandular prathryoidectomy is performed.Other parathyroid-based diseases include primary hypoparathyroidism,which is caused by deficient Parathyroid hormone secretions, and whichin turn can cause low serum calcium due to a lack of Parathyroid hormonemediated bone resorption and calcium reabsorption by the kidneys.Symptoms of hypocalcemia can include neuromuscular irritability andtetany. Intravenous calcium is currently the treatment of choice forprimary hypoparathyroidism, but Parathyroid hormone replacement has alsobeen used to treat primary hypoparathyroidism. However, Parathyroidhormone replacement therapy is costly and most clinicians lack clinicalexperience with this treatment.

Therefore, what is needed are improved methods, devices and systems fortreating parathyroid-based or related diseases and conditions. Thepresent invention is directed to meeting these, as well as other, needs.

SUMMARY OF THE INVENTION

Accordingly, the invention provides methods, devices and systems totreat various parathyroid-based diseases, including but not limited tocalcium metabolism, hyperparathyroidism, hypercalcemia, osteoporosis andthe secondary effects related to the balance of parathyroid hormone andits active elements.

In an alternative embodiment, the invention provides methods for thecontrolled partial or complete ablation of one or more parathyroidglands.

In an alternative embodiment, the invention provides a method forcontrolling the function of the parathyroid function. The parathyroidgland can include but is not restricted to the parathyroid tissue andcells, parathyroid vasculature, parathyroid nerves and the parathyroidlocal tissue.

Controlling the parathyroid gland function can include but is notrestricted to ablating or destroying function or tissue of part or allof the parathyroid gland and can include methods for increasing ordecreasing or modulating the function of the parathyroid gland, whichcan include but is not restricted to altering the release or function ofthe parathyroid hormone. Controlling the parathyroid gland functionshall be referred to as treating the parathyroid gland.

Although the use of minimally invasive therapy (MIT) has been used tokill and treat aggressive or malignant tumors that arise or metastasizeto many organs, the use of MIT to treat hyper-functioning glands hasbeen limited but has been limited predominantly to the thyroid gland.Ethanol (alcohol) percutaneous injections have been used to ablate theparathyroid gland.

Some MIT devices include but are not restricted to Radiofrequencyablation (RF) and microwave (MW) and laser (L), Cryotherapy (CryT),Hight Intensity Focused Ultrasound (HIFU), Radioactive Therapy(Brachytherapy: BrT), Irreversible Electroporation (IRE), ElectricalCurrent Therapies, Electrocautery, Medication delivery, Medicationpackets, blood flow reduction, Chemical and Medication Ablation,Activation and Deactivation and Modulation Therapy, Adhesives and Gluesand Molecular Crystal and Lattice therapies, Target Tissue DeliveryDevice Therapies, Peptide and Biological Conversion Therapies, MR and RFand Magnetic External Heating Therapies, Hyperthermia with AdjuvantTherapy, Hypothermia with Adjuvant Therapy, Local protective therapy inthe Vicinity of the Target Organ Therapy, Suction and Expansion Therapy,Positive Pressure and Expansion Therapy, Mechanical Ablation Therapy andCombinations of Therapies.

The use of MIT for the parathyroid gland (Parathyroid gland) has beenlimited. The use of alcohol ablation has been reported but is of limitedacceptance in part because the use and contact of alcohol in biologicaltissue is extremely dangerous and is poorly controlled. Any leakage ofalcohol outside of the target organ, which in this case is theParathyroid gland can and will likely permanently destroy or damagetissue with which it makes contact. In the case of the parathyroid glandthe tissue in the vicinity of the Parathyroid gland can include but isnot restricted to local nerves such as the Vagus nerve and the RecurrentLaryngeal nerves and vascular structures such as the Carotid artery andthe Jugular vein as well as local organ tissue such as the esophagus.

MIT other than alcohol (ETOH) is proposed as a method to treat theparathyroid gland and hyperparathyroidism. In order to make MIT mosteffective adjustments in the therapy are recommended that achieve fullor partial ablation of abnormal parathyroid tissue or full or partialmodulation of parathyroid tissue function. This means that the MIT musthave enough precision that the targeted tissue such as the parathyroidtissue is treated effectively and the local tissue is preserved. Thiswill result in the return of normal function to the parathyroid hormonalbalance while preserving and not damaging the local tissues such as thenerves and arteries and organs that reside in the vicinity of theparathyroid glands.

This more highly focused treatment is referred to as Tightly TargetedMinimally Invasive Therapy (TTMIT). TTMIT has different strategies andrequires adaptation of present devices and energy and treatmentprotocols and treatment delivery methods and patterns of treatment.

Minimally invasive therapy often is directed to destroy tissue such asmalignant or aggressive tumors. One of the objectives is also to damagethe local healthy tissue adjacent to the malignant or aggressive tumor.This is because the adjacent macroscopically normal tissue oftencontains microscopic malignant or aggressive tumor. This same approachis applicable to the heart and MIT of aberrant nerves and conductivetissue that are responsible for irregular heartbeats such as atrialfibrillation. The discrete location of the nerves to be treated is oftenpoorly defined. As a result MIT is designed to create a penumbra oftissue damage that extends into the interface between normal andabnormal tissue.

The current invention and use of currently available MIT devices andnewly invented MIT devices are designed to limit the damage ordestruction or control or reduction of abnormally functioning tissue ofthe Parathyroid gland and minimize or eliminate the local tissue damage.The techniques and the use of these MIT devices are designed to restrictthe MIT to the Parathyroid gland and reduce or eliminate the affects ofMIT on local tissue or tissue adjacent to the parathyroid gland. Some ofthese techniques and uses will include but are not restricted toablation of the vessels serving the abnormal parathyroid by restrictinginflow and/or outflow of blood from the Parathyroid; severing the neuralconnection to the Parathyroid gland; and eliminating some or all of thefunctioning Parathyroid gland tissue in the abnormal gland that isproducing excess amounts of Parathyroid gland hormone. Partial orcontrolled ablation of the parathyroid glands will be an acceptableendpoint in some patients. The parathyroid gland is fairly unique in thebody. Since there are four normal gland an individual gland can bedestroyed partially or full and normal parathyroid function can bepreserved if at least one normal gland remains. In addition, in somerenal failure patients all four glands can become abnormal. In thosepatients the desired treatment is to remove three of the glands andpreserve a portion of the forth gland. Over time this gland can grow andproduce too much Parathyroid gland hormone. Ablation of a portion butnot all of the remaining Parathyroid gland will become the objective infollow-up treatments. The desired outcome is not to remove allparathyroid tissue from the body which is the objective of malignanttumor removal, but rather the objective is to return the body to normalendocrine function such as but not restricted to returning the calciumblood levels and the parathyroid hormone levels and the parathyroidhormone function back to normal levels and to accomplish this someparathyroid tissue must persist in the body.

Therefore unlike most MIT the treatment objective in the Parathyroidgland is to be able to tightly titrate the ablation of parathyroidtissue so that it is controllable such that either a portion or all ofthe gland can be rendered non-functioning or render at least one butless than four of the glands non-functioning such that by treating onegland the local tissue is not damaged and the other parathyroid glandsare not damaged unless treatment is directed specifically at that otherspecific Parathyroid gland or glands.

The treatment of the parathyroid gland is unique because most otherhormone producing glands of the body are not duplicative, more than onegland and most glands do not have a local environment that contains suchvital and neural and vascular and organ tissue in such close proximity,where the margin of error in treating that gland is as critical as thatof the Parathyroid gland.

Tightly Targeted MIT (TTMIT) could theoretically be used for otherhyper-functioning endocrine tissue and may be useful for ablation ofeven malignant or aggressive tumor tissue that lies near or adjacent tovital structures that cannot be damaged by a penumbra of collateraldamage that can be caused by MIT.

Even the thyroid gland which can develop hyper-functioning nodules andwhich has been treated with MIT methods has very differentcharacteristics than the Parathyroid gland. If the thyroid developshyper-functioning nodules currently the treatment has a much greaterlatitude for error and the destruction of the local normal tissuesurrounding that abnormal nodule is not a significant issue becausethere is usually enough normal thyroid tissue that is preserved thatthere is little to no negative effect in destroying normal tissue andthe fact that the abnormal nodules are embedded in the normal thyroidprotects the local neural and vascular and organ tissue to a muchgreater degree than treatment of the Parathyroid gland. The margin oferror in the MIT of the Parathyroid gland is smaller and less forgivingthan that of the thyroid and makes the objectives and treatmentrequirements very different between the thyroid and parathyroid glands.

Also the parathyroid gland has a relatively unique blood supply. Thebranch arteries and veins associated with Parathyroid gland arededicated to that gland and if these Parathyroid gland vessels can betargeted specifically and ablated or coagulated or reduced in functionthan the functional tissue of the parathyroid can be manipulated andreduced in that specific Parathyroid gland without damaging the otherparathyroid glands and without damaging the function of other localtissue or the local thyroid glands.

The Parathyroid gland is fairly unique because it is encapsulated andhas four stand-alone endocrine glands and one parathyroid or even aportion of one parathyroid gland can be adequate to produce enoughparathyroid hormone to keep the body in parathyroid hormone normalhomeostasis. Therefore, tightly targeted MIT with a smaller or nopenumbra of collateral damage is the goal and is optimal for theParathyroid gland but is less desirable or even not desired for thestandard MIT used to treat aggressive benign or malignant tumors, whichare the primary focus of current MIT treatment. Such TTMIT may even beless optimal for some other endocrine hyper-functioning nodules oradenomas such as the thyroid where the margins of the hyper-functioningnodules or adenomas integrate themselves into the normal thyroid tissuethan it is for the abnormal parathyroid gland.

Other endocrine glands that can be hyper-functioning but in which thepreservation of normal functioning tissue is important can include theadrenals and adenomas of the most superficial cortical layer, the zonaglomerulosa and its production of mineralocorticoids (e.g.,aldosterone); middle cortical layer, the zona fasciculata and itsproduction of glucocorticoids (e.g., cortisol); and the deepest corticallayer, the zona reticularis and its production of weak androgens (e.g.,dehydroepiandrosterone, adrenosterone).

Non-endocrine tissue but tissue that is involved with the production orstimulation or suppression of endocrine tissue can include neural tissuesuch as the pituitary and adenomas of the pituitary such as but notrestricted to prolactinomas. Reduction of the volume of the prolactinomacan both reduce the over-production of prolactin and reduce thecompression of normal pituitary tissue which is compromised by the largesize of the prolactinoma in the sella which is a limited space and whichreduces function of normal tissue function in the pituitary of otherhormone releasing factors such as but not restricted to thyroidstimulating hormone, and anti-diuretic hormone.

Lesions in the brain that are not malignant or aggressive tumors caninclude but are not restricted to abnormal foci of neural activity toinclude but not restricted to seizure foci, aggressive behavior sexualand violent and verbal, and traumatic memories such as memories creatingpost-traumatic stress disorder and infectious foci could also bebenefited by TTMIT.

Tissues that over produce hormones and peptides and chemicals such asbut not restricted to over-production of acid in the stomach by chiefcells, or insulin or glucagons as related to the pancreas could betreated with TTMIT.

One goal of TTMIT is return to normal function such as but notrestricted to hormonal return to normal function of parathyroidfunction. This can be achieved by functional reduction of hormoneproducing cells such that ablation or modulation of the tissue preservesvital normal function but eliminates the excess or non-vital functionespecially in hormonal or peptide producing tissues. It can also be thereturn of normal function of other tissues such as neural tissue andremove or reduce the presence of damaged tissue such as but notrestricted to seizure foci or destructive memories such as but notrestricted to traumatic memories. TTMIT is designed for pinpoint or morerestricted and controlled ablation or down-regulation or decrease incell function without creating larger zones of collateral damage.

Currently, most MIT is designed to fully ablate the tissue target andoften is designed to ablate a margin of tissue often 5 to 10 mm beyondthe primary target.

The parathyroid is unique in that the fact that there are fourparathyroid glands that control calcium metabolism through theparathyroid hormone. When the parathyroid glands develops dysfunction,in general one or two glands become abnormal. TTMIT can be used to treatthe abnormal gland and reduce the amount of abnormal tissue. With renalfailure there can be up to four glands that become abnormal and TTMITcan be used to control abnormal hormonal secretion and can replace theuse of Sensipar, which is a pharmacologic method for treatinghyperparathyroidism and can replace surgery in which 4 glands need to besurgically approached which can lead to hypoparthyroidism. The preferredembodiments can to be used for treating the parathyroid gland andcontrolling excess chemical peptide or hormonal secretion. In otherembodiments, the current treatment can be used to control excesssecretion of other hormone or peptide or chemical secreting organs. Theparathyroid glands are relatively unique compared to most peptide orhormone secreting organs because of their multiplicity and theirtendency to become hyperplastic or adenomatous and offers an opportunityto control function.

BRIEF DESCRIPTION OR FIGURES

FIG. 1 is a frontal view, anatomic rendering of the thyroid andparathyroid glands in the anterior mid neck.

FIG. 2 is an isolated view of the parathyroid gland.

FIG. 3 is a rendering of a device that can be used to penetrate the skinand the subcutaneous tissue to reach the parathyroid gland.

FIG. 4 is a rendering of a guiding device with a blunt end. Inside ofthe guiding device is a tube/conduit that can have one or more than onechannel.

FIG. 5 is a rendering of a guiding device penetrating the parathyroidtissue. In one embodiment the tube can be a needle can have athread-like configuration that penetrates the parathyroid with ascrew-like motion or mechanism.

FIG. 6 is a rendering of a guiding sheath penetrating the parathyroidgland 30. There can be an additional tube or additional guiding sheaths,and these conduits can provide for the passage of a device and theguiding devices can serve multiple functions to include but notrestricted to insulation for the local tissue and delivery of asubstance to the target tissue.

FIG. 7 is a rendering of a guiding device penetrating the parathyroidtissue. There can be an additional tube or guiding device, and theseconduits can provides for the passage of a substance and can servemultiple functions to include but not restricted to insulation.

FIG. 8 is a rendering of one embodiment of a transcutaneous energydelivery device for ablating one or more parathyroid glands, which cancontain a passageway or conduit through the transducer for the transportof a solid or hollow tube or device or probe or an additional conduitdevice. The passageway device through the transducer can be built intoor separate from the transducer.

FIG. 9 is a rendering of a transcutaneous device and one or more tubesor devices or delivery systems or conduits such as a needle or probesthat can penetrate the skin and subcutaneous tissue to reach and canpenetrate the target tissue and its vascular supply and nerves to treatthe target tissue, parathyroid gland, or non-target tissue in thevicinity of the target tissue.

FIG. 10 is a sagittal cross-sectional rendering of the thyroid 20 and anormal superior parathyroid gland, target tissue and an abnormalinferior parathyroid gland. The trachea lies adjacent to and posteriorto the thyroid and the two parathyroid glands. A delivery device caninclude or not include a sensor sensitive delivery device that canprotect the non-target vicinity tissue and modulate treatment to thetarget tissue.

FIG. 11 is a tube or conduit or needle percutanueously depositing asubstance/s, which in the preferred embodiment can include in standardradioactive seeds for brachytherapy. THE delivery system can include aneedle with a stylet with interlocking grooves or thread and a methodand device for governing the transit of the stylet and needle for thedelivery of the brachytherapy or non-brachytherapy substances.

FIG. 12 is an example of a device that can utilize but is not restrictedto electromagnetic or kinetic or thermal or mechanical energy ormethods. The device can be composed of an elongated member that can adistal component that can deliver the treatment such as an RF ormicrowave or laser probe and a second or component which can be locatedmore proximal to the distal component that is insulated or prevents thedeposition of treatment to the tissue that is more proximal to thedistal component that can deliver the treatment. Sensors and controlsand generators and feedback mechanisms and loops can be used to regulatetreatment to both the target tissue, parathyroid gland and the localvicinity tissue.

FIG. 13 is an embodiment of one or more a tubes or conduits such as aneedle or guiding sheath and each can contain one or more channels orlumens that extend through at least a portion of or the entire length ofthe tube or conduit and can be used to biopsy or deliver treatment tothe target tissue, parathyroid gland, or the local vicinity tissue.Sensors can be used or be a component of the tubes or conduits.

FIG. 14 is an embodiment of a percutaneous device and a guiding tubethat can combine hot thermal and cold thermal energy for treatment. Thecombination of differing thermal elements can be switched on and off tocontrol the precise temperature, and the device can include a sensingdevice.

FIG. 15 a is an embodiment of a treatment delivery device to include butnot restricted to a laser, RF, or microwave probe that can have anenergy delivery probe component and an insulating component that can befixed or not fixed. In this embodiment an insulated guiding tube orconduit can assist in altering the energy delivery. FIG. 15 b is anembodiment where the relationship of the energy delivery device or probecomponent and the insulating component and the guide are not fixed andthe length or surface area of the treatment device can be increasedand/or decrease which is done in FIG. 15 b is done by rotating oradvancing or retracting or any combination of movements of theinsulation or the guide or the treatment device relative to the eachother. In FIG. 15 c on embodiment can include a laser treatment deviceand two conduits that contain openings that can include but are notrestricted to slits or holes that serve as fenestrations or windows tothe laser light. When the conduit fenestrations are not aligned theamount of light or heat escaping the two conduits and reaching thetarget tissue is more limited than when the fenestrations are aligned.

FIG. 16 is an embodiment in which a percutaneously placed treatmentdevice resides within the target tissue, parathyroid gland and one ormore tubes/conduits/catheters or needles or devices can be placed intothe local vicinity tissue and can introduce a substance or energy, whichcan include but is not restricted to Dextrose 5% water that is chilledprior to instillation or chilled after or during instillation from athermal treatment device, which can include but is not restricted to athermal probe or a cooling needle that can include cold or heat and canbe infused or placed into the local vicinity tissue and can serve as aheat-sink to protect the local vicinity tissue if heat is the primarythermal treatment to the target tissue or can include warming to protectthe local vicinity tissue if cryotherapy is the primary thermaltreatment to the target tissue.

FIGS. 17 a,b is a simplified diagram of the zone of ablation. Thetreatment device is placed into the target tissue and a central areaadjacent to the probe or treatment device is irreversible ablated. Inthe MIT there are multiple zones of ablation that are of intermediate orpartial damage to the vicinity tissue beyond the target tissue andextending into the vicinity or local non-target tissue. With TTMIT theenergy deposition or the substance deposition or the local protectivetreatment are designed to reduce the vicinity or local non-target tissueto as minimal an area as possible even possible at the reducedeffectiveness of the treatment of the target tissue. FIG. 17 ademonstrates MIT with a zone of ablation that that affects both theparathyroid target tissue and the vicinity tissue whereas, with FIG. 17b TTMIT only the parathyroid gland is ablated.

FIG. 18 a is an embodiment of one probe or device or FIG. 18 b multipleprobes within the target tissue 1 parathyroid gland.

FIG. 19 a,b,c is a depiction of the temperatures of heating and theirdestructive nature. This can be altered by the duration of time that thetarget tissue is exposed to these temperatures and is dependent on thesize and location of the target tissue that is being treated.

FIG. 20 is a delivery device that can include but is not restricted to atube or catheter or conduit, needle or guide that can have side-holes orfenestrations of variable size that can be greater in diameter proximalthan distal or greater in diameter distal than proximal or anycombination of sizes of side-holes.

FIG. 21 a is a tube or catheter or conduit, needle or guide, which canhave a variable sized distal end hole or the end of a conduit can beclosed and contain no end-hole and be closed at the distal end. Theconduits can be partially or fully composed of insulation and theinsulation can include but is not restricted to insulation fromelectromagnetic, thermal, kinetic or mechanical forces or energy. In oneembodiment a laser energy delivery device can reside within an insulatortube/catheter or conduit, which can have a variable sized holes and canmodulate or alter the lasers effect upon the target tissue, includingthe parathyroid gland. In FIG. 21 b in one embodiment this can useside-holes or fenestrations that can be of variable size and shapeincluding geometric and non-geometric and logarithmic and logarithmicpaper shapes or cut-outs on a logarimthic pattern and can include one ormore than one a tube/catheter or conduit, needle or guide, which canhave a variable sized distal hole and a guide or sheath that is closedat the distal end and in Figure and these insulating tubes or conduitscan move or rotate to expose greater or lesser amounts of the energytreatment or substance for treatment to the target tissue, parathyroidgland. This embodiment can include a laser treatment device and twoconduits that contain openings that can include but are not restrictedto slits or holes that serve as fenestrations or windows to the laserlight. When the conduit fenestrations are not aligned the amount oflight or heat escaping the two conduits and reaching the target tissueis more limited than when the fenestrations are aligned. This can alsobe organized on a logarithmic graph pattern with cut out slits that cantightly control the amount of light that is emitted to the targettissue.

FIG. 22 is a device that delivers a substance to the target tissue, theparathyroid or the vicinity tissue. The substance is a substance thatcan modulate the function of the target tissue, the parathyroid. Thedevice can include a pump and sensor that responds to physiologicparameters and the substance delivered can activate or deactivate thetarget tissue.

FIG. 23 a is a target tissue marker or localizing device that can beused to include but not restricted to a surgical marker or localizingdevice, a percutaneous treatment marker or localizing device or atranscutaneous treatment marker or localizing device. The marker orlocalizing device can consist of a substance solid or liquid or gel orgas such as but not restricted to methylene blue and gentian violet,tattoo inks. In FIG. 23 b is a fluorescent or UV sensitive dyes, orfluorescein or in FIG. 23 c an injected material can be metal or aradio-opaque material or FIG. 23 d radioactive material or in FIG. 23 eGPS device or an FIG. 23 f LED device. The marker or localizing devicecan be constructed to screw into the target tissue.

FIG. 24 a is a guide/wire/placement device 70, a stylet 57 or a tube 52or needle 58 that can leave a marker/localizing device 40 in the targettissue 1, parathyroid. In one embodiment the marker/localizing device 40can contain a transitional zone 45 that contains a transitional statesensitive substance 99 that can be converted from a solid or liquid/gelmaterial that when exposed to a substance 99 or an energy source such asbut not restricted to electromagnetic energy, kinetic or mechanical orthermal energy or forces changes its state and can separate from the amore solid or gel state to a state where the placement device 70 isseparated from the marker/localizing device 40. In one embodiment theplacement material and the transitional material and themarker/localizing device can all be metallic and if energy 100 such asan electrical current or a thermal force is transmitted though theplacement wire the transitional zone 45 will separate from themarker/localizing device. In another embodiment the placement devicematerial 70 can be composed of a gel that when cold 96 remains solid butwhen heated 98 the transitional zone will melt or dissolve after a givenperiod of time and separate from the marker/localizing device 40.

FIG. 24 b is a placement device that can have groove/threads 66 thatwhen turned or moved in the proper manner will unthread.

FIG. 24 c is an embodiment where the gel can take on crystallinecharacteristics and become more rigid or less rigid when exposed toelectromechanical or kinetic or mechanical energy.

FIG. 24 d is an embodiment of a marker/localizing device 40 can beplaced into the target tissue 1, the parathyroid gland 30 and themarker/localizing device can be attached to a continuous filament/thread38 that can be made of a material that can be organic but not restrictedto silk, cotton or hemp or inorganic such as but not restricted tocarbon filaments or metal.

FIG. 24 e is an embodiment of a marker/localizing device 40 can beplaced into the target tissue 1, the parathyroid gland 30 that can bechanged in shape by and energetic or thermal energy or substance 99 toinclude but not restricted to being straight to pierce the parathyroid30 target tissue 1 and can take on a shape that creates resistance tobeing removed such as a corrugated shape.

FIG. 25 is an embodiment in which a guide 50, guide wire 52, wire/thread53, placement device 70, a stylet 57 or a tube 52 or needle 58 or hooks60 or probes/tines/electrodes 94 can have transitional physicalcharacteristics similar to and can be incorporated into themarker/localizing device but can also be used separately without amarker or localizing device. FIG. 25 a depicts a stylet when exposed tocold becomes rigid and straight and when exposed to a designated heatbecomes flexible. FIG. 25 b depicts a hook that when exposed to coldbecomes rigid and straight and when exposed to a designated heat becomesflexible.

FIG. 26 a is an insulated tube or catheter or conduit, needle or guide,guide wire, wire or thread, placement device, or a stylet, theinsulation can be an insulation substance; in FIG. 26 b a chamber thatcan be filled with a substance that can insulate including a vaccuum; orin FIG. 26 c a substance that can circulate substances to form a heatsink.

FIG. 27 is an embodiment in which a guide 50, guide wire 52, wire orthread, placement device, a stylet or a tube or needle is placed into ofadjacent to the target tissue and hooks or probes/tines/electrodes canbe used to maintain the position of the target tissue, parathyroidgland. In one embodiment FIG. 27 a there can be a form of positivepressure created inside the target tissue 1, parathyroid gland 30. Inanother embodiment FIG. 27 b the pressure exerted inside of theparathyroid can be negative pressure.

FIG. 28 is an embodiment of a guide, guide wire, wire or thread,placement device, a stylet or a tube or needle or hooks that can becomposed of a carbon-carbon or ceramic based structure with a tensilestrength that can be greater than, less than, or equal to an equivalentor similar device with the standard metal qualities for a similar useand that pierces the skin and subcutaneous tissue can be composed of acutting material that can include but is not restricted to diamond orzirconium or hardened metal and can include but are not restricted tothe leading edge or tip that has a sharpened cutting edge.

FIG. 29 a is an embodiment in which a form of delivery packets oragitating substance can be delivered percutaneously ornon-percutaneously and can be used to deliver a substance such asmedication to ablate the target tissue. In FIG. 29 a the substancedelivered through the delivery packet does not require a secondsubstance or energy source for activation. In FIG. 29 b the substancedelivered through the agitation substance or delivery packet doesrequire a second substance or energy source for activation. In FIG. 29 cthe substance delivered through the agitation substance or deliverypacket does require a second substance or energy source for activationand the energy source can through a transcutaneous device such as butnot restricted to ultrasound.

FIG. 30 is an embodiment of a viewing screen or display. In oneembodiment the screen can be in the form of goggles or mask or glasses.Data and images can be displayed on the screen or projected from thegoggles to the retina. The data can be transmitted by hardwiring or bynon-wire methods, such as but not restricted to WI-FI. In addition, thegoggles or mask or glasses display can also protect a portion of theuser's body or face from harmful substances or from energy.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In the current invention, methods for more pinpoint and precisetargeting without heating may be achieved by irreversibleelectroporation (IRE) and this may prove an optimal method for treatingthe abnormal Parathyroid gland. Methods for more pinpoint and precisetargeting with heating may be effectively used on the Parathyroid glandusing high-intensity focused ultrasound (HIFU). IRE and HIFU as well asother MIT and TTMIT methods including but are not restricted to MW, RF,L, CryoT, and chemical ablative techniques, adjuvant therapy, chemotherapy or radiation or any combination of these methods can be used inconjunction with but not restricted to small local incisions orlaparoscopy or percutaneous needle placement in or near or adjacent tothe tissue such as but not restricted to the Parathyroid gland.

Ischemic ablation is a primary mechanism of Parathyroid gland treatment.Thrombosing the arterial inflow leads to ischemia and cell death, whileeliminating venous outflow results in Parathyroid gland interstitialtissue increased pressure and resultant cell death by osmotic and toxicmeans and by secondary ischemia and cell death if the Parathyroid glandintra-gland pressure exceeds arterial inflow pressure. Ischemic ablationcan be achieved by using high-intensity focused ultrasound (HIFU). IREand HIFU as well as other MIT and TTMIT methods including but are notrestricted to MW, RF, L, CT, and chemical ablative techniques, adjuvanttherapy, chemo therapy or radiation or any combination of these methodsor methods described within this patent.

Strategies for optimally treating the parathyroid gland may include butare not restricted to modifications of the antenna and electrode and caninclude but are not restricted to changing antenna and electrode lengthand changing insulation lengths, limiting the maximal heating of theprobe with longer durations of the pulse, alternating pulses of shortand long, creating a probe in which the insulation or the electrode canbe made to vary to be shorter and longer, adjustments of the pulsingsequence with feedback from the damage rendered to the gland or theheating or the cooling in the vicinity tissue, enlargement of theelectrode face or tines, individually retractable tines or electrodeswhich can adjust to target tissue shape and response to therapy of thetarget tissue and the local vicinity tissue, alternating and variableheating and cooling and a change and must frequently a reduction in theratio of heat or electromagnetic or kinetic energy delivered to ablatethe target tissue compared to heat or electromagnetic or kinetic energydelivered in the tissue in the vicinity of the target tissue.

One embodiment can include hooks to secure the parathyroid gland andthese hooks can be non-heat conducting and insulated or heat conducting.

Direct and primary tissue destruction is another primary mechanism ofParathyroid gland treatment. Mechanisms utilized to directly destroy acell can include but are not restricted to heat, cold, chemical,osmotic, pressure and suction and mechanical, electromagnetic includingbut not restricted to casing a current through the tissue, and nuclearenergetic destruction. Delivery and treatment mechanisms can include butare not restricted to IRE, HIFU, MW, RF, L, CryoT, chemical and adhesiveand osmotic and packet delivery systems can include but are notrestricted to liposomes and microbubbles and activated and deactivatedmaterials that can be deactivated or activated by a second substance ortreatment to include but not restricted to de-carboxylation andde-methylization and activation and inactivation with electromagneticenergy to include but not-restricted to visible light and UV to controlthe degree of tissue damage in the target organ and in the localenvironment. Other methods for modulating tissue exposure to heat andcan include but are not restricted to exposing the tissue and the localtissue and non-target tissue to cooling solutions such as but notrestricted to chilled such as chilled or frozen distilled water ionicsolutions and non-ionic solutions; ionic solutions such as but notrestricted to saline, non-ionic solution such as but not restricted to5% Dextrose water or distilled water.

In general heating for hyperthermic device have a heat and a duration ofexposure to that heat. Tissue damage can occur at heats above 46 degreesC. for 60 minutes but other embodiments can include but are notrestricted to heating and duration to include successful ablation oftissue at 70 degrees C. for 60 seconds as a single exposure or two 70degree C. exposures each for 30 seconds. Generated power can includemany different power generated setting and another embodiment caninclude but is not restricted to 150 Watts producing 100 degrees for 10minutes.

In another embodiment of radiofrequency ablation, a high-frequency,alternating current with a wavelength of 460-500 kHz can be emittedthrough an electrode placed within the targeted tissue Grounding padsapplied to the patient's thighs complete the electrical circuit.Deposition of radiofrequency energy results in frictional heating fromflowing electrons in cells near the site of energy emission. When livinghuman tissues are heated to more than 49° C., cell death occurs withinminutes. Temperatures in excess of 60° C. can cause immediate celldeath. The cell death is induced by the denaturation of proteins, whichresults in the loss of enzymatic function, melting of cell membranes,mitochondria function and destruction of cytoplasm. These events resultin direct cyto-destruction of the affected cells. Although some cellsare destroyed at temperatures less than 49° C., other cells can survivetemperatures approaching 49° C. Alternatively, when temperatures exceed105° C., cells boil, releasing gas vapor and causing tissue charring.Gas and charred tissue inhibit dispersion of radiofrequency energy,which decreases the effectiveness of some heating and penetration oflethal energy concentrations. Hence, radiofrequency ablation devicesshould ideally induce prolonged heating of target tissue withtemperatures sustained between 50° and 105° C.

For percutaneous imaging-guided radiofrequency ablation, the energy isdelivered into the target tissue by means of needlelike electrodes.Radiofrequency ablation electrodes can include but are not restricted toa range in a diameter from 15 to 17 gauge. Each of these devices uses adifferent strategy to maximize the size of thermal ablation. In oneexample a system by Radionics can have an electrode that can be shapedlike a standard 17-gauge needle and delivered as a single electrode oras a unit of three electrodes arranged in a triangular cluster. TheRadionics system increases ablation lesion size by using twoenhancements: electrode cooling and pulsed energy delivery. TheRadionics device consists of a generator and a 14- or 15-gauge electrodewith numerous retractable tines, which are used to increase the area ofablation. The tines are advanced into the area of treatment. The LeVeensystem uses a 14-gauge electrode with 12 retractable tines that areadvanced into the area of treatment. Each device also uses a slightlydifferent approach to energy delivery and monitoring for thermaldestruction.

The theoretical maximum size of the treatment zone has been calculatedin vitro for radiofrequency ablation. In vitro, the theoretical maximumsize of the ablated area is two times the length of the energy-emittingsegment of the electrode for the long axis of the treatment zone. Thetransverse axis maximum can be up to two-thirds of the length of thelong axis of the treatment zone. In vivo, the treatment zone varies andis usually smaller than the theoretical maximum. The maximum size of thetreatment zone can be increased by inducing ischemia or by treatingdevascularized tissue. Alternatively, flowing blood, largefluid-containing spaces, or circulating air can decrease the effectivesize of the treatment zone. The available radiofrequency devices usegenerators that deliver 150-200 W of energy.

These heating characteristics may vary from device to device but thegeneral principles of cell death apply to multiple forms of treatment.

Calculating which treatment is optimal for the given target tissue, suchas the size and location of the Parathyroid gland adenoma will require acase-by-case individual analysis. A Parathyroid gland adenoma that is30×12×18 mm and is not near vital arteries or neural structures willneed to be treated with different wattage, and power and maximal heatingand time duration and number of applications or pulses of the treatmentthan a Parathyroid gland adenoma that is 10×8×12 mm and lies in closeproximity to vital arteries or neural structures.

Thermal Ablation Therapies can include but is not restricted to thefollowing.

Thermal ablation requirements for benign tissue that over-producehormone such as but not limited to the parathyroid gland differ fromcarcinomas and malignant behaving tumors because if some functioning orover functioning cells remain this does not pose a serious threat to thesurvival of the organism being treated. One example is a parathyroidgland that is 90% ablated may acceptable and may reduce Parathyroidgland hormone levels back to a normal or acceptable range, whereas a 90%kill rate of malignant or aggressive tumor cells would not beacceptable. In addition, if a Parathyroid gland is found to beover-producing parathyroid hormone after one treatment, then a secondtreatment can be employed whereas that same strategy if applied to anorganism with malignant or aggressive tumors carries increased risk tothat organism when failing to eradicate malignant or aggressive tumormalignant cells on the first treatment and thus is significantlydifferent and carries greater risk to an organism with a malignant oraggressive tumor than the failure to eradicate some percentage of cellsin a benign tumor or mass or adenoma or non-malignant or aggressive cellpopulation. In fact, treatment of the Parathyroid and other benign cellsthat are over-producing hormone may be treated effectively if not moreeffectively with multiple treatments, so as to limit or reduce the riskof damage to the structures in the vicinity of the target tissue such asbut not restricted to the parathyroid gland. If multiple parathyroidadenomas are present or if there is a mixture of parathyroid hyperplasiaand adenomas them treating the parathyroid adenoma first and observingthe organisms return to normal calcium homeostasis and parathyroid glandproduction may warrant a ‘watch and wait’ policy and not demand anyfurther treatment until the organisms calcium homeostasis or parathyroidgland hormone levels become abnormal. In summary, the treatment ofbenign parathyroid tissue that is hyper-producing parathyroid hormonecan be treated with MIT such that the balance of aggressiveness oftreatment is on the side of caution and protection of non-target tissuewhereas with a malignant tumor the balance of aggressiveness is moreheavily weighted toward destroying the malignant or aggressive tumor.

In one embodiment thermal ablation therapies can either increase ofdecrease the temperature of the tissue being treated of which the twobasic strategies are cryotherapy and hyperthermic therapy, respectively.These therapies induce cell cytotoxicity, irreversible cell destructionand death and necrosis.

The parathyroid gland is unique in that parathyroid hormone levels canreturn to normal in 10 to 30 minutes after effective removal ortreatment of the abnormal parathyroid tissue.

Hyperthermic therapies that induce cytotoxicity are believed to begin atabout 46 degrees Celsius (C) for about 60 minutes within the tissue.

Thermal ablation therapies can include but are not restricted toradiofrequency ablation (RF) and microwave (MW) and laser (L) utilize anoptimal temperature of 50 degrees C. and heating of tissue to 50 to 54degrees C. for 4-6 minutes is a common endpoint for irreversiblecytotoxicity. But higher temperatures are generated by the RF or MW or Ldevices to include 100 degrees, such that the tissue adjacent to thedevice can experience temperatures of 100 degrees C. which coagulatesthe adjacent tissue and higher temperatures such as 105 degrees C. tovaporize the adjacent tissue.

In the current invention heat-sinking can be used to reduce local tissuedamage. Heat-sinks from blood vessels reduce tissue damage and reducetissue temperature. Heat-sinking in the current techniques is a drawbackand reduces effectiveness of MIT. Or a heat-sink can be created by butnot restricted to bathing the target tissue in cooler solutions. Alsothe target tissue can be isolated or insulated from the non-targettissue. Or the target tissue can be surrounded by a material thatreflects or locks-in the heat on the target but spares surroundingtissue such as but not restricted to a heat-conducting material on theinside facing the target and an insulating material on the outsidefacing the local tissue to be protected.

Hypothermic or Cold Therapy or Cryotherapy (CryoT) can include but isnot restricted to:

In one embodiment hypothermic or Cold or Cryotherapy (CryoT) is thetreatment of tissue with lower than normal organic temperatures.Temperatures below 0 degrees C. can create freezing to target tissues.Temperatures of minus 20 to minus 40 degrees C. represent the lethalisotherm although the temperatures often used by cryothrapy devicesrange as low as minus 140 degrees C. inside the iceball used fortreatment or heat-sink of 9 kJ (kilojoules). Many of the limitationssuch as clefts that exist with malignant or aggressive tumor ablationare not relevant with Parathyroid gland treatment. Needles and probesfor treating the Parathyroid gland can be small, as small as 13-gauge(2.4 mm) or smaller because of the Parathyroid gland target requirementsbut larger probes with size equal to or greater than 15-gauge (1.7 mm)probes may prove effective in the Parathyroid gland. Cryoprobes aredesigned to create a heat sink and gasses and materials such as but notrestricted to Argon, helium and nitrogen can be utilized.

In another embodiment the use of liquid materials such as Nitrogen thatcool when allowed to return to a gaseous state can also beprecutaneously delivered to the target organ such as the Parathyroidgland.

Various cryoprobes exist that include but are not restricted toreservoirs that contain coolant materials such as but not restricted tonitrous oxide and needles that serve as heat-sinks that can use but arenot restricted to argon gas.

In one embodiment, the balloon portion of the catheter is filled with acoolant which applies subzero Celsius temperatures to tissue. In anotherembodiment the temperature can be less than subzero or alternatingtemperatures of subzero, zero and above zero can be applied to controlthe amount of damage to the target tissue, such as but not restricted tothe Parathyroid gland.

In another embodiment one or more probes can be used and separated by adistance to maximize tissue death between the probes but also takinginto account the zone and radius of ablation.

Or the target tissue can be surrounded by a material that reflects orlocks-in the heat on the target but spares surrounding tissue such asbut not restricted to a heat-conducting material on the inside facingthe target and an insulating material on the outside facing the localtissue to be protected.

Chemical and Medication Therapy can include but is not restricted to thefollowing.

In one embodiment ethanol has been used to ablate parathyroid glands butthe risk to local tissue damage such as the neural and vascular andorgan tissue is significant because of the uncontrolled nature ofinjecting Ethanol because it denatures living tissue.

In another embodiment methods whereby substances are injected around theParathyroid gland can include but are not restricted to water, saline,weak bases such as but not restricted to calcium or sodium bicarbonatecan be used to dilute or the tissue surrounding the Parathyroid glandcan be neurtralized by ethylene glycol or propylene glycol or glycerolor glycerine.

Other chemicals or sclerosants which have not been used but may provemore effective because of their less toxic nature and their greatercapacity to be neutralized and can include but are not restricted toacetic acid and other moderate and weaker acids, weaker forms of alcoholor diluted forms of alcohol or other sotradecol.

Substances that can be injected can be in the solid, liquid, gel orgaseous states or can form a slurry or a mixture or combination of thesolid, liquid, gel or gaseous states. Other substances may include butare not restricted to carbon monoxide, saline or dextrose solutions thatare saturated in a manner that damages the target tissue which can alsobe optimized or constructed or delivered to protect the non-targettissue.

In another embodiment the tissue adjacent to the target tissue can betreated with a that is substance that is protective or can dilute thenon-target tissue environment and can include but is not restricted to athe solid, liquid, gel or gaseous states or can form a slurry or amixture or combination of the solid, liquid, gel or gaseous states andthat substance is non-toxic and will serve as an antidote or dilute orneutralize the effects of the toxic substance injected into the targettissue such that if the toxic substance leaks out of the target tissueor region the being treated such as but not restricted to theParathyroid gland. One example is injecting carbon monoxide into theParathyroid gland and placing oxygen in the adjacent tissue. Anotherexample is injecting ammonia or urea into the target organ whileflooding the adjacent tissue with saline to dilute the effect of theammonia or urea.

Substances that can be injected can be in the solid, liquid, gel orgaseous states or can form a slurry or a mixture or combination of thesolid, liquid, gel or gaseous states. Other substances may include butare not restricted to carbon monoxide, saline or dextrose solutions thatare saturated in a manner that damages the target tissue. Also thetissue adjacent to the target tissue can be treated with a substancethat is in the solid, liquid, gel or gaseous states or can form a slurryor a mixture or combination of the solid, liquid, gel or gaseous statesand that substance is non-toxic and will serve as an antidote or diluteor neutralize the effects of the toxic substance injected into thetarget tissue such that if the toxic substance leaks out of the targettissue or region the being treated such as but not restricted to theParathyroid gland. One example is injecting carbon monoxide into theParathyroid gland and placing oxygen in the adjacent tissue. Anotherexample is injecting ammonia or urea into the target organ whileflooding the adjacent tissue with saline to dilute the effect of theammonia or urea.

Other forms of chemicals for cauterizing tissue, specifically bloodvessels can include but is not restricted to silver nitrate,Trichloroacetic acid and Cantharidin, an extract of the blister beetlethat causes epidermal necrosis and blistering.

Electromagnetic therapy can include but is not restricted to thefollowing.

Radioactive (Brachytherapy)

Radioactive materials, brachytherapy, can be used to percutaneouslyplace electromagnetic energy into the target tissue to modulate controlof biological function in tissue that is functioning in an aberrantmanner. In one embodiment bachytherapy can be used in an hyperactiveParathyroid gland. In one embodiment the radioactive seeds can beimplanted and left in place and the isotope which uses a low dose ofradiation (brachytherapy) with a limited zone of radiation can be usedand can include but is not restricted to iodine-125 or palladium-103. Inanother embodiment a high radiation dose isotope can be inserted intothe Parathyroid gland for a limited period and then removed and this caninclude iridium-192 which would be inserted into the Parathyroid glandpercutaneously for less than 15 minutes. The dose is dependent upon thesize of the Parathyroid gland adenoma and the tissue in the vicinitythat may be sensitive to the irradiation. In the preferred embodimentthe radiation would be introduced through a percutaneous guide andguiding system.

Radiofrequency Therapies

In one embodiment during Radiofrequency probe ablation an electricalcurrent oscillates through the ion channels that are inherently presentin biological tissue. Since biological tissue is an imperfect generatorof electrical current, frictional agitation and heat are produced. Thisis known as the Joule effect. Tissue heating is greatest nearest theprobe and more distant tissue receives a thermal conduction and thusheat drops off away from the probe. Augmentation of the RF effect can beperformed by increasing the probe surface area, pulsing the input powerand injecting saline/ionic solutions.

RF ablation can use a single or multiple tines. The needles can beinsulated and cooled by water. Tines come in many shapes andconfiguration and multiple gauge sizes approximating 14 gauge (2.1 mm)to 17 gauge (1.5 mm) For the purpose of the Parathyroid gland glandsmaller gauge probes, one or two tines and smaller tines may provide asmaller and more controlled zone of tissue damage.

The multipolar or bipolar RF probe may prove more effective than themonopolar probe in the Parathyroid gland. With the multipolar andbipolar RF probe the current oscilates between the two electrodes.Saline can be instilled within the Parathyroid gland to augment thetissue damage between these two electrodes each of which can be placedat the superior and inferior aspect of the abnormal parathyroid glandwhile monitoring needle placement using imaging guidance techniques toinclude but not restricted to real-time ultrasound. Initially, levels ofpower begin in the 20 to 50 W range but may need to increase dependenton the impedance of the tissue being treated and the adjuvant such assaline and ionic solutions administered. Also by pulsing the generatorthe size of the tissue lesion can be controlled. Since pulsingalgorithms have been shown to increase ablation zone size and decreasethe time for treatment, the Parathyroid gland gland may be bettertreated with an algorithm that decreases the ablation zone and is lessconcerned with treatment time.

RF can be applied in a unipolar or a bipolar or multipolar fashion andthe inter-electrode distances can vary depending on the tissue andelectrode characteristics (e.g. 5 mm, 10 mm) and the size of theparathyroid target tissue. RF energies can vary (e.g 500 kHz) that aredelivered to the target tissue to include but not restricted to 100 J,101-200 J, 201-300 J, 301-400 J, 401-500 J, 501-600 J, 601-1000 J,and >1000 J. Results of tissue damage show that when RF energy isapplied in a bipolar fashion, the lesions are located between and aroundthe electrode and when applied in a unipolar fashion lesions were foundin the catheter/tissue interface. Bipolar mode increased the length ofablation and can but is not restricted to allow for one treatment pulse.

In another embodiment the tip of the electrode can be varied. The largerelectrode tip appears to create larger lesion. Therefore depending onthe size of the target tissue such as but not restricted to theParathyroid gland the size of the electrode tip will be determined bythe size of the needle desired for the percutaneous approach with agauge size of 21 (0.72 mm) being optimal and a size as large as being 15gauge (1.5 mm) approaching the maximal size for safe percutaneousprocedures. The electrode tip may be limited by these parameters. Inanother embodiment a bipolar or multipolar device can be used where thetines spread out as they exit the percutaneous introducer.

In one embodiment anchors or fixation hooks can be employed to stabilizethe target tissue such as the parathyroid gland during treatment.

In one example of target tissue ablation the RF energy sufficient tomaintain a highest temperature of 100° C. can be delivered for 8-10minutes for each ablation. The impedance values ranged from 30 to 60Ω.The diameters of the deployed hooks varied between 1 and 3 cm, dependingon the target tissue's size and location. The temperature of each hookcan be maintained above 90° C. For masses or lesions smaller than 2 cmin diameter, the needle tip was placed in the center of the lesion andthe hooks were deployed to reach the deepest margin of the malignant oraggressive tumor or lesion. One ablation was usually enough to destroythe entire target tissue. For larger target tissue, multiple overlappingablations can be performed (range, two to six ablations) according tothe size and shape of the target tissue.

With multi-tined probes a target zone of 3 m can be produced by threetines 17 gauge spaced 5 mm apart at 200 w for 12 minutes. This is likelygreater than would be safe for a Parathyroid gland even if it were 3 cmgiven the collateral zone injury that may occur and decreased durationor energy would likely be indicated in vivo for a large Parathyroidgland (3 cm).

Microwave Ablation

In one embodiment, in the biological system the term microwave ablationdescribes electromagnetic energy typically at either 915 MHz to 2450Mhz, although microwave refers to electromagnetic energy between 300 MHzand 300 GHz. If microwave energy is continuously applied it can resultin temperatures >150 degrees C. in biological tissues. Antennas areneedle like or looped. Current biological systems in general aremonpole, dipole or slotted with the smallest gauge system being 13gauge.

Microwave ablation refers to the use of all electromagnetic methods forinducing lesion or tumor destruction by using devices with frequenciesof at least 900 MHz). Microwave radiation refers to the region of theelectromagnetic spectrum with frequencies from 900 to 2450 MHz. Thistype of radiation lies between infrared radiation and radio waves. Watermolecules (H2O) are polar; that is, the electric charges on themolecules are not symmetric. The alignment and the charges on the atomsare such that the hydrogen side of the molecule has a positive charge,and the oxygen side has a negative charge. Electromagnetic radiation haselectric charge as well; the “wave” representation is actually theelectric charge on the wave as it flips between positive and negative.

For a microwave oscillating at 9.2, 108 Hz, the charge changes signsnearly 2 billion times a second (9.2 108 Hz). When an oscillatingelectric charge from radiation interacts with water molecule, it causesthe molecule to flip. Microwave radiation is specially tuned to thenatural frequency of water molecules of the parathyroid gland tomaximize this interaction. As a result of the radiation hitting themolecules, the electrical charge on the water molecule flips back andforth 2-5 billion times a second depending on the frequency of themicrowave energy. Temperature is a measure of how fast molecules move ina substance, and the vigorous movement of water molecules raises thetemperature of water. Therefore, electromagnetic microwaves heat matterby agitating water molecules in the surrounding tissue, producingfriction and heat, thus inducing cellular death via coagulationnecrosis.

One embodiment can include but is not restricted to a thin (14.5-gauge)microwave antenna is placed directly into the target tissue, such as theParathyroid gland. When the antenna is attached to the microwavegenerator with a coaxial cable, an electromagnetic microwave is emittedfrom the exposed, non-insulated portion of the antenna. Each generatoris capable of producing 60 W of power at a frequency of 915 MHz and onesuch percutaneous microwave ablation system (Vivant Medical, MountainView, Calif.).

Different configuration exist for MW antennaes which include but are notrestricted to Tiaxial, Slotted and Choked. Given that the Choked is 99%efficient and given its profile of ablation and that it can be producedin 9-10 gauge antennaes this may prove the current optimal antenna forthe Parathyroid gland adenoma.

Laser Ablation

In one embodiment laser sources include but are not restricted toneodymium-doped yttrium alunum garnet and semi-conductor diodes thatemit approximately 600-1000 nm wavelength light energy. Laser may beideal for the Parathyroid gland ablation. Limitations and disadvantagesthat exist for lasers with lesions and tumors and other tissueapplications may prove beneficial for the Parathyroid gland. Laser lightis an efficient and precise for tissue heating. Laser light when itstrikes body tissue becomes scattered and absorbed rapidly this causeslasers to have limited energy penetration and thus produce smaller zonesof ablation (10 to 20 mm) than other devices. Light also does notpenetrate charred and damaged tissue. The Parathyroid gland adenomas arecommonly 15 mm or less making laser treatment ablation optimal for theParathyroid gland adenomas.

Medical lasers that can include but are not restricted to CO2 lasers,diode lasers, dye lasers, excimer lasers, fiber lasers, gas lasers, freeelectron lasers, and optical parametric oscillators.

In one embodiment laser irradiation can be performed with a 1.064-nmNd:YAG laser and variable wattage can include 2, 3, 5, or 7 W and totaldelivered energy of 500, 1,000, 1,500 or 2,000 J, respectively. One ormultiple illuminations can be performed. Between 600 and 1600 J for alesion of approximate size of 10 mm maximal length may prove optimal forthe Parathyroid gland of that length but the treatment parameters willultimately be dependent on the actual size of the Parathyroid glandadenoma and its location to vital neural and arterial structures.Low-energy output (2-5 W per fiber) close to the implanted fiber tip,the temperature exceeds 100° C. and results in vaporization of the coreof the lesion. Laser advantages include a precise zone of tissue damage.

Ultrasound Ablation

HIFU Ultrasound devises are greater than 13 gauge. HIFU can be used totrascutaneously ablate lesions. One embodiment can include but is notrestricted to a 1.06 MHz HIFU transducer which can be used over atreatment diameter of approximately 45.2×18 3-mm rectangular opening.The HIFU transducer was spherically focused, with a 63 t 3 mm geometricfocus, 64-mm active diameter, and an 18×45-mm2 rectangular cutout toenable coaxial placement of a linear array and the transducer can bedriven continuously at its operating frequency increasing uniformly from3.6 to 8.0 MPa at variable exposure durations (eg 2, 5, or 10 seconds).Typically the HIFU can generate temperatures between 65 and 85 degreesCelsius. Typical diagnostic ultrasound transducers deliver ultrasoundwith time-averaged intensities of approximately 0.1-100 mW/cm2 orcompression and rarefaction pressures of 0.001-0.003 MPa, depending onthe mode of imaging (B-mode, pulsed Doppler sonography, or continuouswave Doppler sonography). In contrast, HIFU transducers deliverultrasound with intensities in the range of 100-10,000 W/cm2 to thefocal region, with peak compression pressures of up to 30 Mpa and peakrarefaction pressures up to 10 MPa.

Electrical current therapy and Irreversible Electroporation (IRE) andElectrocautery Therapy can include but are not restricted to thefollowing.

In one embodiment Irreversible Electroporation (IRE) may prove the mosteffective means of treating Parathyroid gland adenomas because itproduces no excess heat. Cells are eradicated by using several micro tomillisecond pulses of electrical current and generate fields up to 3kV/cm, which irreversibly damage cell membranes and generate apoptosis.IRE is little affected by heat sinks and creates less damage to collagentissue and nerves thus is optimal for the Parathyroid gland which hasthe Recurrent Laryngeal nerve and the Vagus in its close vicinity. IREalso can use a thin 19 gauge needle (1.1 mm) that is insulated, largerneedles are also available. A single needle bipole electrode isavailable or multiple electrodes can be implanted. The electricalcurrent can involve high voltage pulses, which are less frequentlyapplied or lower voltage pulses which may require several hundredpulses.

Coagulation may be limited with IRE and this injection of coagulationfactors into the Parathyroid gland after the application of IRE to theParathyroid gland may be useful adjunct medication.

In another embodiment an electrocautery device can be used smilar tothose used in surgery to cauterize blood vessels whereby an electricalcurrent heats the cautery device and the heated tip is place on or inthe Parathyroid gland and destroys the living tissue, specifically thiscan be targeted to the blood vessels of the Parathyroid gland and cancause electrocoagulation of the Parathyroid gland blood vessels.

In another embodiment Electrocautery can be combined with othertreatment modalities to include but not restricted to IrreversibleElectroporation (IRE). IRE does not coagulate vessels in the same manneras thermal methods of treatment and to decrease the risk of bleedingfrom the target tissue such as but not restricted to the parathyroidgland blood vessels, electrocautery may be needed to control belleding.

Parathyroid Arterial Blood flow reduction can include but is notrestricted to the following.

In one embodiment injection of arterial and arteriolar vasospasticagents such but not restricted to as epinephrine and epinephrine-likemedications can assist with MIT and TTMIT of the Parathyroid gland.Additionally other pharmacologic agents designed to reduce tissueperfusion can include but are not restricted to halothane and arsenictrioxide and antiangiogenic therapies such as but not restricted tosorafenib can be used in combination with TTMIT or alone to treatParathyroid gland adenomas. All the MIT and TTMIT modalities can be usedalone or in combination to control and target the target tissue arterialand venous blood flow as the primary or secondary site for resultantablation.

Medication Carrying Packets Therapy can include but is not restricted tothe following.

In one embodiment medication agents can include but are not restrictedto organic or inorganic agents and pharmacologic agents and biologicalagents can be carried in packages that can deliver these agents totarget tissues. This can include but is not restricted to deliverythrough the bloodstream, CSF or through catheters, or needles or otherpercutaneous methods.

Carrying packages can include but are not restricted to liposomes whichcan include but are not restricted to mulilamellar vesicles, smallunilamellar and large unilamellar vesicles and microbubbles which arebubbles smaller than a millimeter. Microbubbles can be filled withperfluorocarbon or air or other gasses or can be filled with othermaterials to include but not restricted to medication agents andpharmacology agents and biological agents. The microbubble shell canconsist of but is not restricted to lipids or proteins that can includebut are not restricted to serum albumin.

Carrying packets can be but are not restricted to being sensitive tomechanical and vibration or electromagnetic energy including but notrestricted to UV or infrared or visible light sensitvive or they can betemperature dependent (hyper or hypothermic) exposure or pH or solids orthey can be sensitive to exposure to liquids or gasses or a combinationof the above which can cause the carrying packets to release thecontents of the carrying packet. This may allow the Parathyroid glandtissue to be effectively treated with a lower energy deposition becausethe carrying packet agent/s are augmenting the destruction of the targettissue to include but not restricted to the Parathyroid gland tissue,while allowing the local tissue to be exposed to an energy dose belowthe local tissues threshold for damage.

In another embodiment microbubbles can be used to treat the targettissue. The instillation of microbubbles into the target tissue whichcan include but is not restricted to direct percutanous instillation ofthe microbubbles into the target tissue, the Parathyroid gland. Usingmechanical or vibrational or ultrasonic stimulation the microbubbles caninteract with the Parathyroid gland tissue intact or they can releasetheir contents and this process can modulate the ablation of theParathyroid gland tissue by either acting as a secondary adjuvant, or arepressor of the primary treatment modality. In one example themicrobubbles can interact with the vibrational effect of ultrasound orHIFU and augment the heating or destruction of the Parathyroid gland.This may allow the target tissue to include but not restricted to theParathyroid gland tissue, to be effectively treated with a lower energydeposition because the microbubbles are augmenting the destruction ofthe tissue, while allowing the local tissue to be exposed to an energydose below the local tissues threshold for damage. Microbubbles can beformed with various materials to include but not restricted to galactoseand other related organic carbohydrates, proteins and fats as well asother organic and inorganic compounds.

Activation and Deactivation and Modulation of the treatment therapy ordevice can include but is not restricted to the following.

In one embodiment medication agents can include but are not restrictedto electromagnetic and mechanical or kinetic energy and organic orinorganic agents and pharmacologic agents and biological agents can bemodulated by either activating or deactivating the agent using one ormore additional modulating agents to include but not restricted toelectromagnetic energy such as but not restricted to ultraviolet light,or radiation; kinetic or thermal energy to include but not restricted tohyper-thermic delivery systems, ultrasound energy or vibrational forces;cryotherapy or hypo-thermic delivery systems; or liquids, fluids, gelsor solids that can include but are not restricted to medications orsolvents.

Light is a type of electromagnetic radiation and can be used to activateand deactivate substances. This is a form of photochemical reaction, andfollows the Grothuss-Draper Law. Photo/Electromagnectic andmechanical/vibration energy can can also change the configuration of amolecule or molecular configuration and change its properties enablingon otherwise inaccessible molecule to become accessible(Woodward-Hoffman selection rules) or creating an accessible moleculeand making it inaccessible. Some of the most widely used sections of theelectromagnetic spectrum are UV 100-400 nm, visible light 400-700 nm andNear Infrared 700-2500 nm. Examples of photo activation can include butare not restricted to photosynthesis, Vitamin D conversion,bioluminescence, phenol and tetraphenylporphorine, hydrocarbon solventsthat use short wavelengths and solvents containing unsaturated bondsthat may require higher wavelengths, cyclohexane, acetone and singletoxygen reactions in general. Cis and Trans rotations of the moleculethat can occur in alkenes. Other reactions can include mercaptans,toluene-chlorine, and metallic reactions like UV irradiation of THFsolution of molybdenum hexacarbonyl. Transform a liquid into a crystalcan be used to alter the internal structure of the Parathyroid gland.One reaction can include but is not restricted to photolysis of ironpentacarbonyl. Also carbon nanotubes can be placed into the targettissue and exposed to an intense pulsed light from a laser or an arclamp. This will produce combustion and temperatures as high as 700 to1500 degrees C. Another crystal reaction can include alpha-snatonin whenexposed to sunlight wavelengths.

The electromagnetic source can include a multichromatic light sourcesuch as mercury vapor lamps or monochromtic light sources such as LED orRayonet lamps.

Some activation examples can include but are not restricted toultraviolet activated persulfate oxidation of phenol in the basic pHconditions. Carbon foam using a coal tar pitch as a precursor can serveas a support for titanium oxide for the catalytic degradation of phenol.Activation of medications with electromagnetic energy or mechanicalenergy from an activated form to a deactivated or from a deactivatedform to an activated form for can modulate the rate and speed of thereaction inside of the target tissue specifically the Parathyroid glandor outside of the target tissue.

Adhesives and Glues and Molecular Crystal and Lattice therapies caninclude but is not restricted to the following.

In one embodiment the injection of medical grade adhesive into theParathyroid gland can be an effective means for ablating a part or allof the Parathyroid gland. In the preferred embodiment the adhesive canbe percutaneously instilled into Parathyroid gland or into the adjacenttissue or the blood vessels associated with the Parathyroid gland andcan include but are not restricted to cyanoacrylate adhesive. UV-curableadhesive (e.g. Cyberlite U303), two part filled epoxy (e.g. Cyberpoxy5895), anaerobic threadlocking adhesive, which is thixotropic (e.g.Titan 7222), methyl methacrylate,

In one embodiment a substance which can include but is not restricted toa solid, liquid, gel or gas can be injected into the target tissue thatcan include but is not restricted to the Parathyroid gland that isinactive in its primary state but can become activated if a secondsubstance which can include but is not restricted to a solid, liquid,gel or gas is added such as but not restricted to epoxy glues such asbut not restricted two part filled epoxy (e.g. Cyberpoxy 5895).

In another embodiment electromagnetic energy can be added to the primarysubstance, which can include but is not restricted to a solid, liquid,gel or gas can be activated by an energetic source that can include butis not restricted to electromagnetic energy, radiation, heat, kineticand mechanical energy and can include UV activated compounds such as butnot restricted to UV-curable adhesive (e.g. Cyberlite U303). Otherembodiments can include combinations of substances and energetic sourcesas primary or secondary or additional additives.

The absence of a substance, which can include but is not restricted to asolid, liquid, gel or gas can also activate a primary substance and caninclude but is not restricted to the absence of one or more gases suchas with anaerobic adhesive.

In another embodiment is a lattice or compound that can be placedpercutaneously within the target tissue that can contain a substancewhich can include but is not restricted to a solid, liquid, gel or gaswhich can surpress or activate or treat the target tissue. Oneembodiment can include a substance that is placed into the Parathyroidgland glans and can include but is not restricted to a lattice such ashydroxyappetitie, Ca5(PO4)3(OH), Ca10(PO4)6(OH)2, or bone meal, calciumcarbonate, hydroxylapatite, hydroxylapatite hydo-gel or Cinacalcet(Sensipar) or a related calcimimetic substance or a Parathyroid glandsurpressing agent.

Target Tissue Delivery Device Therapies can include but is notrestricted to the following.

In another embodiment a delivery device can be used to percutaneouslydeliver a compound that can be directly delivered within the targettissue such as but not restricted to the Parathyroid gland and the thatsubstance which can include but is not restricted to a solid, liquid,gel or gas can surpress or activate or treat the target tissue.

In one embodiment a delivery system for the target organ such as notrestricted to the Parathyroid gland can emulate a diabetic insulin pumpthat measures glucose blood levels and delivers insulin to the bloodstream. For the Parathyroid gland the pump would measure Parathyroidgland hormone levels or a form of calcium levels to include but notrestricted to ionized calcium or bound or unbound calcium in the bloodstream and deliver calcium or a form of calcium or a surpressor oractivator of the Parathyroid gland such as Cinacalcet or relatedcalcimimetic substance or a Parathyroid gland surpressing agent.

Other embodiments can include but are not restricted to a scaffold orholding structure or slow dissolving or time release substance that caninclude but is not restricted to a lattices or crystals that can beinjected percutaneously adjacent of within a lesion or tumor and thecrystals or lattices can contain a to medications to treat the medicalmalady or lesion or tumor through the slow release of the compound. Inone embodiment the medication can be placed in the healthy tissueadjacent to the lesion or tumor and as the tumor attempts to grow thelesion or tumor encounters the lattice and treating or suppressing oractivating medication that can include but is not restricted to achemotherapeutic or anti-angiogenic agent that limits the growth of themalignant or aggressive tumor beyond or outside its current or naturalconfines.

Another embodiment embodiments can include but are not restricted to ascaffold or holding structure or slow dissolving or time releasesubstance that can include but is not restricted to a lattices orcrystals that can be injected percutaneously adjacent to or within alesion or tumor and the crystals or lattices can contain a tomedications to treat the medical malady or adenoma or lesion or tumorthrough the slow release of the compound. In one embodiment themedication can be placed in the healthy tissue adjacent to the lesion ormalignant or aggressive tumor and as the lesion or tumor attempts togrow the lesion or tumor encounters the lattice and treating orsuppressing or activating medication that can include but is notrestricted to a chemotherapeutic or anti-angiogenic agent that limitsthe growth of the lesion or tumor beyond or outside its current ornatural confines

Peptide and Biological Conversion Therapies can include but are notrestricted to the following.

In another embodiment substances or peptides or peptide analogs toinclude but not restricted to portions of the parathyroid molecule whichcan include the active portion of the molecule. Molecule or mineralssuch as Calcium or organic or inorganic compounds that can bind toreceptors such as Sestimibi, Sensapar (Cinacalcet) or Calcium analogcompounds that are related to the parathyroid receptors can be used tothe parathyroid binding receptors and can utilize methods for reversibleor irreversible attachment.

Biological compounds that simulate Parathyroid gland hormone or itsprecursors or calcium, Sensapar (Cinacalcet) or Sestimibi relatedcompounds or compound that do not egress the parathyroid can beconstructed with biological or chemical denaturing agents or lyticqualities or tissue destructive qualities can be injected percutaneouslyinto the parathyroid and create Parathyroid gland cell death. Thesecompounds or substances can include biological agents that bind tocellular elements to include but not restricted to cell membranes,nucleus, mitochondria, DNA, RNA, parathyroid hormone or its precursors,or other cellular structures or cellular products. This can include butis not restricted to acetylation with carboxylic acid, formic, acetic,benzoic or other acids and can include toxic materials such asthalidomide or arsenic. For peptide modification this can include but isnot restricted to modification at the C-end or the N component of thepeptide.

MR and RF and Magnetic External Heating Therapies can include but arenot restricted to the following.

In one embodiment ferromagnetic particles can percutaneously be placedinto the Parathyroid gland and the MRI machine sequences can then beengaged. If Electromagnetic and mechanical and Radiofrequency Excitation(RF) and SAR (heat depositing sequences) are used then the ferromagneticparticles will heat up and can reach temperatures that can be modulatedto reach greater than 46 degrees C. Also there will be movement of theferromagnetic particles that will create Brownian motion or mechanicalmovement of the particles that will mechanically damage the Parathyroidgland cells. The size of the ferromagnetic particles can be microscopicand as small as particles that are angstroms or nanometers to particlesthat are macroscopic and in the order of size from micrometers tomillimeters. These ferromagnetic particles can be in the solid, liquid,gel or gaseous states or can form a slurry or a mixture or combinationof the solid, liquid, gel or gaseous states.

Hyperthermia with Adjuvant Therapy can include but are not restricted tothe following.

In another embodiment, non-ferromagnetic substances can be injected intothe Parathyroid gland and the natural heating of the MRI from theElectromagnetic and mechanical and RF and SAR (heat depositingsequences) are utilized and focused in the region of the Parathyroidgland then the target tissue, specifically the Parathyroid gland canexperience heating that damages the Parathyroid gland.

Another concept is to lower the boiling point of a substance such thatthe substance is injected into the target tissue and then a hyperthermicsource is administered to the target such as the Parathyroid gland andthe amount of heat that is needed to damage the target tissue because ofthe presence of the adjuvant substance which can include but is notrestricted to a solid or liquid or gel or gas is a temperature thatcreates minimal or no damage to the adjacent tissue. In anotherembodiment the a substance can be injected adjacent to the target tissuethat can keep the target tissue safe from the effects of hyperthermia.

In one embodiment water or saline can be percutaneously injected intothe target tissue, the Parathyroid gland and the heating by the MRI RFwill heat the tissue of the Parathyroid gland and destroy the gland. Inanother example a substance which can include but is not restricted to asolid or liquid or gel or gas with a boiling point lower that water canbe injected and the MRI or external RF can be focused onto theParathyroid gland. At one atmoshphere some of the compounds with boilingpoints lower than water that can be injected include but are notrestricted to Acetaldehyde CH3CHO, Acetone CH3COCH3, Acetylene,Alcohol-ethyl (grain, ethanol) C2H5OH, Ammonia, Benzene (Benzol) C6H6,Bromine, Carbon bisulfide, Carbon dioxide, Carbon disulfide CS2, Carbontetrachloride CCl4, Chloroform, Cyclohexane, Diethyl ether, Ether,Ethanol, Ethyl acetate CH3COOC2H3, Ethyl bromide C2H3Br, Hexane-n,Hydrogen, Methanol (methyl alcohol, wood alcohol), Methyl acetate,Propane, and Propylene. The heating of the target tissue, theParathyroid gland, can include but is not restricted to external sourcesas with MRI RF or HIFU or percutaneous or internal body sources such asbut not restricted to RF and microwave. The internal source of heatingcan be within the target tissue or in the vicinity or adjacent to thetarget tissue.

In another embodiment the desired goal may be to expose the targettissue probes or delivery systems and adjuvant substances that exceedthe boiling point of water. This is more likely to cause damage to thebiological tissue. Some examples of injected substances can includesaline water, glycerine, and ethyl bromide.

In another embodiment the flashpoint can be used to treat the targettissue such as but not restricted to the Parathyroid gland can beinjected with a substance which can include but is not restricted to asolid or liquid or gel or gas and when heated will attain a flashpointat or below a temperature that does not damage tissue adjacent to thetarget tissue such as but not restricted to the Parathyroid gland.Substances with low flashpoints that are still in the safe range foradjacent biological tissue can include but are not restricted toethanol.

Hypothermia with Adjuvant Therapy can include but are not restricted tothe following.

In another embodiment the concept is inject a substance that can includea solid, a liquid, a gel or a gas that can lower the freezing pointabove that of water (e.g. substance and tissue freezes at 10 degrees C.rather than 0 degrees C. as occurs with water) such that the substanceis injected into the target tissue and then a hypothermic therapy isadministered to the target tissue such as the Parathyroid gland and theamount of cold that is needed to damage the target tissue because of thepresence of the adjuvant substance is a temperature that creates minimalor no damage to the adjacent tissue. In another embodiment a substancecan be injected adjacent to the target tissue that can keep the targettissue safe from the effects of hypothermia.

In one embodiment water or saline can be percutaneously injected intothe target tissue, the Parathyroid gland and cooling or freezing bycryotherapy and hypothermia of the tissue of the Parathyroid gland willdestroy the gland. In another example a substance with a freezing pointhigher that water can be injected into the targeted tissue and thecryotherapy can be focused onto or placed into the Parathyroid gland. Atone atmosphere some of the compounds with freezing points higher thanwater that can be injected include but are not restricted to Helium,Hydrogen, neon, fluorine, oxygen, nitrogen, Argon Chlorine, Bromine,acetic acid, benzene, and phenol.

In another embodiment the desired goal may be to be lower than freezingpoint of water. This is more likely to cause damage to the biologicaltissue. Some examples of injected substances can include but are notrestricted to ethanol and water and glycerol.

Local protective therapy in the Vicinity of the Target Organ Therapy caninclude but is not restricted to the following.

Multiple examples have been given of local protective therapies aroundthe target tissue.

Examples can include but are not restricted to, one example in whichhyperthermia is applied to the target tissue and the tissue adjacent tothe targeted tissue can be bathed in 5% or greater Dextrose Water.

In one example a toxic material injected into the target tissue such asthe Parathyroid gland will be a material where the optimal injectedmaterial will be low or no toxicity to the local biological tissue whenthe local biological tissue that is not the target. If the localnon-target tissue is diluted or given an antidote material or if it isheated to a safe level the local tissue will remain safe even if thetoxic material leaks out of the Parathyroid gland it will have minimalnegative biological effect such as but not restricted to injection ofammonia into the Parathyroid gland but injection of saline into adjacenttissue; heating of local tissue to less than cytotoxic levels of heatwhile the Parathyroid gland at the same heat levels will experiencecytotoxicity because it received an adjuvant substance into theParathyroid gland. These injected substances can be in the solid,liquid, gel or gaseous states or can form a slurry or a mixture orcombination of the solid, liquid, gel or gaseous states and can includeferromagnetic substances, saline, water, ammonia, bromine, carbondioxide, carbon disufide.

In another embodiment if hypothermia or cryothermia are used then thelocal environment in the vicinity of the target tissue, which caninclude but is not restricted to the Parathyroid gland, can be infusedwith solutions or substances that depress the freezing point such as butnot restricted to sorbitol, glycerol, glycogen, glucose, sodium chlorideor substances with increased molality compared to water. These can alsoinclude supersaturated solutions or combinations of these substances.

Mechanical Ablation Therapy can include but is not restricted to thefollowing.

In another embodiment a percutaneous technique can include placing aneedle into the target tissue, such as but not restricted to theParathyroid gland. This can include but is not restricted to amechanical cutting or ablating or cutting tool or cell masceration andtissue damaging device. The mechanism of mechanical damage can includebut is but restricted to a blade, a needle, a burr. a compressive force,a stream or flow of focused material to include a solid or liquid or agas or gel to include water, oxygen, a hydrogel or hot metal or liquidnitrogen.

Methods of delivering the mechanical force can include but are notrestricted to a needle with one or more end-holes, side-holes, orcombination of these end and side hole and a cutting device that caninclude a blade, a needle, a burr. a compressive force, a rotatingforce, a stream or flow of focused material to include a solid or liquidor a gas or gel to include water, oxygen, a hydrogel or hot metal orliquid nitrogen.

A negative suction that is continuous or pulsed can remove tissue thatenters the core of the needle.

Suction and Expansion Therapy can include but is not restricted to thefollowing.

In another embodiment a percutaneous technique can include placing ahollow needle or catheter or guide that lies within or intimatelyadjacent to the target tissue, such as but not restricted to theParathyroid gland. A negative pressure can be applied within the needlehollow needle or catheter or guide such that the blood flow to theparathyroid gland is inhibited and or ceases and thus creating anischemic state within the parathyroid tissue and thus resulting in celldeath and cytolysis.

This negative pressure can be combined with a cutting tool that caninclude a side-hole in the needle and a cutting or mechanical devicethat can include a burr or a blade that can remove tissue that entersthe core of the needle. The needle or guide or catheter can have one ormore channels and each channel can be dedicated to the same or differenttasks.

Positive Pressure and Expansion Therapy can include but is notrestricted to the following.

In another embodiment a percutaneous technique can include placing aneedle into the target tissue, such as but not restricted to theParathyroid gland. Positive pressure can be applied within the needle.This will create positive pressure within the target tissue such as butnot restricted to the Parathyroid gland. To create the positive pressurea substance can include but not restricted to a solid, liquid, gel orgas or a combination can form a slurry or a mixture or combination ofthe solid, liquid, gel or gaseous states can be instilled though theneedle into the target tissue. The objective is to create enoughpositive pressure within the tissue of the Parathyroid gland to exceedsystolic pressure and prevent the inflow of blood into the parathyroidgland and secondarily create ischemia within the Parathyroid. In oneembodiment this supra-systolic pressure, pressure above systole in thetarget tissue, will be maintained until the target tissue ischemia issufficient to achieve cytolysis and target tissue cell death.

This positive pressure can be combined with a cutting tool that caninclude a side-hole in the needle and a cutting device or mechanicaldevice that can include a burr or a blade that can remove tissue thatenters the core of the needle. The needle or guide or catheter can haveone or more channels and each channel can be dedicated to the same ordifferent tasks.

Combinations of Therapies can include but is not restricted to thefollowing.

Therapies can be used in isolation or in combination. Multiple therapiescan be combined such as but not restricted to hyperthermia with adjuvanttherapy and MR heating with ferromagnetic or HIFU with adjuvant therapyand local protective therapy.

Nerve Sensory Device can include but is not restricted to the following.

Prior to the procedure a nerve stimulator can be activated then thetherapeutic needle tip or guide or probe is in place and prior totherapeutic treatment, The stimulator is designed to determine whetherthe local nerves adjacent or near to the Parathyroid gland including butnot restricted to the Laryngeal nerves, the Recurrent Laryngeal nervesand the Sympathetic and parasympathetic nerves as will as other visceraland pain nerves. will be affected by the treatment. In one example a lowvoltage stimulation can be applied with a lesion generator (e.g. 0.1-0.2V at 50 Hz, RFG-3CF, Radionics, Burlington Mass.) to insure that theadjacent an critical nerves are not stimulated. Motor stimulation can beapplied to the region (e.g. 0.1-0.2 V at 2 Hz).

Monitoring of laryngeal nerves can also be monitored using standardforms of intraoperative laryngeal and laryngeal nerve monitoring andIntraoperative EMG.

Temperature probes can be utilized to assess the local tissueenvironment by percutaneous insertion of a probe or temperaturemeasuring device. Said measuring device can have the capacity to turnoff the treatment generator and sicontinue or limit or modulatetreatment. The probe can also be located in or on or adjacent to thetrachea, larynx and airway.

In another embodiment another form of sensory probe can be a device thatsenses electromagnetic signals to include but not restricted to electriccurrent. These can include but are not restricted to modifications ofHall sensors with field concentrators, AMR current sensors,magneto-optical and superconducting current sensors, Hall effect ICsensor, Resistor, whose voltage is directly proportional to the currentthrough it, Fiber optic current sensor, using an interferometer tomeasure the phase change in the light produced by a magnetic field,Rogowski coil, electrical device for measuring alternating current (AC)or high speed current pulses, galvanometer is a type of ammeter: aninstrument for detecting and measuring electric current and electrometeris an electrical instrument for measuring electric charge or electricalpotential difference. The sensory probe can be placed in the vicinity ofthe target tissue and in the case of the Parathyroid gland can be placeadjacent or near the Parathyroid gland specifically near the neuralstructures such as the laryngeal nerves or major blood vessels.

Needles or percutaneous penetrating cylinder or solid or hollow tubedevice can include but is not restricted to the following.

In another embodiment is a needle or probe or percutaneous cylinder ortube (which can be hollow or solid) device (all can be referred to hereas a needle) can be composed of a metallic substance that can includebut is not restricted to stainless steel, aluminum, iron, titanium orother ferrous materials and alloy.

A device that penetrates the skin or passes through human tissue can bebut is not restricted to a needle or probe or tines or percutaneous tubedevice and hereafter will be referred to as a needle. The needle can bemade to consist of fully or partially of optimal insulating materials orcan be insulated with a material on the outside portion of the needle,on the inside portion of the needle if the needle is hollow, acombination of inside and outside of the needle, the needle can becomposed of multiple metallic and non-metallic materials to include butnot restricted to good insulators and poor conductors of heat and canalso be composed of materials that can include but are not restricted toceramic materials, high aluminum ceramics (Alumina Ceramic), beryllium,fiberglass, Zirconium, High Zirconium, adhesives and nansulators,reinforced carbon-carbon fiber construction (aka carbon-carbon,abbreviated C/C) is a composite material consisting of carbon fibrereinforcement in a matrix of graphite, Carbon fibre-reinforced siliconcarbide (C/SiC) is a development of pure carbon-carbon (C/SiC utilisessilicon carbide with carbon fibre, and this compound is thought to bemore durable than pure carbon-carbon), Fibrous refractory compositeinsulation (FRCI), LI-900 silica tiles, made from essentially very purequartz sand, High-temperature reusable surface insulation (HRSI),Reaction Cured Glass (RCG) of which tetrasilicide and borosilicate glassare some of several ingredients to waterproof the coatingdimethylethoxysilane is injected into the coating (densifying the tilewith tetraethyl orthosilicate (TEOS) also helps to protect the silicaand waterproof), RCC (a laminated composite material made from graphiterayon cloth and impregnated with a phenolic resin. After curing at hightemperature in an autoclave, the laminate is pyrolized to convert theresin to carbon. This is then impregnated with furfural alcohol in avacuum chamber, then cured and pyrolized again to convert the furfuralalcohol to carbon. This process is repeated three times until thedesired carbon-carbon properties are achieved the outer layers of theRCC are converted to silicon carbide. The silicon-carbide coatingprotects the carbon-carbon from oxidation.

In one embodiment the needle can contain a diamond or zirconium tip.

Needle with chambers that can circulate substances to form a heat sinkcan include are but not restricted to solids, liquids and gels andgasses or a vacuum. These can substances can include but are notrestricted to water, argon, nitrogen, and nitrous oxide or a vacuum.

In another embodiment the needle have chambers that contain substancesor vacuum that are non-circulating.

These needle can be used for additional applications where insulation isnot a requirement.

In another embodiment the needle can be coated or composed with anansulatecoating which can include but is not restricted to aninsulation technology that incorporates a nanocomposite calledHydro-NM-Oxide, a product of nanotechnology. This material is documentedas having one of the lowest measured thermal conductivity values. (0.017W/mK). Nansulate, when fully cured, contains approximately 70%Hydro-NM-Oxide and 30% acrylic resin and performance additive. It doesnot function as a metallic UV radiator (reflection). The nano-particlein Nansulate act to inhibit the heat flow much like traditionalinsulation.

In another embodiment the needle can have but is not restricted to anouter or inner coating that provides for decreased resistance ordecreased friction from the tissue through which it penetrates. This caninclude but is not restricted to a coating or composition that caninclude but is not restricted to a Polytetrafluoroethylene (PTFE) orfluoropolymer of tetrafluoroethylene or a hypophillic or hydrophobicmaterial, ultra-high-molecular-weight polyethylene (UHMWPE) or mineraloil or molybdenum disulfide embedded as additional lubricants in theneedles matrix.

In another embodiment the needle can have but is not restricted to avariable or non-uniform flexibility and tensile strength within itslength or width.

In another embodiment the needle can have but is not restricted to avariable width of its wall or lumen. In one example the wall can bethicker proximal that distal such that the needle or catheter has theconfiguration or an a triangle or arrowhead that allows for easierpenetration.

In another embodiment the needle can have but is not restricted to achamber that can be filled with a substance that can include a solid orliquid or gel or gas that can be filled to include but not restricted toit being under pressure and causing the needle or catheter wall toharden or become more firm such that it can pierce the skin more easily.Once it has reached its target the chamber material can be withdrawnfully or incompletely or the nature of the material can be altered. Inon example the catheter or needle chamber can be a nitenol or alloymetal that when cooled is firm but when heated is soft and pliable andflexible.

In another embodiment the needle can be composed of but not restrictedto a material to include but not restricted to material such as nitenolor alloy metal that when cooled is firm but when heated is soft andpliable and flexible or other materials that have variable hardness orsoftness under differing thermal conditions such as hot or cold, orelectromagnetic conditions such as UV light or the presence or absenceof an electric current of a magnetic force to include but not restrictedto Ferrofluids such as colloidal liquids made of nanoscaleferromagnetic, or ferrimagnetic, particles suspended in a carrier fluidsuch as an organic solvent or water, magnetorheological fluids (MRfluids), nanoelectromechanical systems, magnetorheological fluid (MRF)refers to liquids similar to ferrofluids (FF) that solidify in thepresence of a magnetic field. These materials can contain and includebut are not restricted to material that contain magnetite, hematite orsome other compound containing iron that are small enough for thermalagitation to disperse them evenly within a carrier fluid, and for themto contribute to the overall magnetic response of the fluid and caninclude but is not restricted to the composition of a typical ferrofluidis about 5% magnetic solids, 10% surfactant and 85% carrier, by volume.In other embodiment the ferromagnetic particles can be arranged in amanner that can be circular or spiral or other geometric ornon-geometric arrangements that can alter or vary the shape or firmnessor flexibility of the needle.

One of the uses for this type of needle can include but is notrestricted to serve as a rigid penetrating device to reach the targettissue as it penetrates the skin or organs or vessels but then canbecome flexible and not damage the tissue any further when it is changesto a non-rigid device.

The variable stiffness can include all or only one or more portions ofthe needle.

The needle can include multiple configurations and its cross section caninclude a geometric or non-geometric or variable configuration that caninclude but is not restricted to a curved or circle, or ellipseconfiguration or an angled or straight or, triangle, rectangle,pentagon, hexagon etc, configuration.

A stylet or guide or introducers can include but is not restricted tothe following.

The stylet or guide or introducer in the preferred embodiment caninclude but is not restricted to a device that can be placed within theinside hollow of device such as but not restricted to a needle orcatheter or it can be placed on the outside of a needle or catheter.Some of the functions of the stylet or guide or introducer can includebut are not restricted to stiffening the path, protecting, guiding,introducing, or filling the hollow of the device or needle or catheteror any combination of uses.

In another embodiment is a stylet or guide or introducer or probe orpercutaneous cylinder or tube (which can be hollow or solid) device canbe composed of a metallic substance that can include but is notrestricted to stainless steel, aluminum, iron, titanium or other ferrousmaterials and alloy.

A device that penetrates the skin or passes through human tissue andstiffening the path, protecting, guiding, introducing, or filling thehollow of the device or needle or catheter or any combination of usesbut not restricted to these uses and can be but is not restricted to astylet or guide or introducer or probe or tines or percutaneous tubedevice and hereafter will be referred to as a stylet or guide orintroducer. The stylet or guide or introducer can be made to consist offully or partially of optimal insulating materials or can be insulatedwith a material on the outside portion of the stylet or guide orintroducer, on the inside portion of the stylet or guide or introducerif the stylet or guide or introducer is hollow, a combination of insideand outside of the stylet or guide or introducer, the stylet or guide orintroducer can be composed of multiple metallic and non-metallicmaterials to include but not restricted to good insulators and poorconductors of heat and can also be composed of materials that caninclude but are not restricted to ceramic materials, high aluminumceramics (Alumina Ceramic), beryllium, fiberglass, Zirconium, HighZirconium, adhesives and nansulators, reinforced carbon-carbon fiberconstruction (aka carbon-carbon, abbreviated C/C) is a compositematerial consisting of carbon fibre reinforcement in a matrix ofgraphite, Carbon fibre-reinforced silicon carbide (C/SiC) is adevelopment of pure carbon-carbon (C/SiC utilises silicon carbide withcarbon fibre, and this compound is thought to be more durable than purecarbon-carbon), Fibrous refractory composite insulation (FRCI), LI-900silica tiles, made from essentially very pure quartz sand,High-temperature reusable surface insulation (HRSI), Reaction CuredGlass (RCG) of which tetrasilicide and borosilicate glass are some ofseveral ingredients to waterproof the coating dimethylethoxysilane isinjected into the coating (densifying the tile with tetraethylorthosilicate (TEOS) also helps to protect the silica and waterproof),RCC (a laminated composite material made from graphite rayon cloth andimpregnated with a phenolic resin. After curing at high temperature inan autoclave, the laminate is pyrolized to convert the resin to carbon.This is then impregnated with furfural alcohol in a vacuum chamber, thencured and pyrolized again to convert the furfural alcohol to carbon.This process is repeated three times until the desired carbon-carbonproperties are achieved the outer layers of the RCC are converted tosilicon carbide. The silicon-carbide coating protects the carbon-carbonfrom oxidation.

In one embodiment the stylet or guide or introducer can contain adiamond or zirconium tip.

Stylet or guide or introducer with chambers that can circulatesubstances to form a heat sink can include are but not restricted tosolids, liquids and gels and gasses or a vacuum. These can substancescan include but are not restricted to water, argon, nitrogen, andnitrous oxide or a vacuum.

In another embodiment the stylet or guide or introducer have chambersthat contain substances or vacuum that are non-circulating.

These stylet or guide or introducer can be used for additionalapplications where insulation is not a requirement.

In another embodiment the stylet or guide or introducer can be coated orcomposed with a nansulatecoating which can include but is not restrictedto an insulation technology that incorporates a nanocomposite calledHydro-NM-Oxide, a product of nanotechnology. This material is documentedas having one of the lowest measured thermal conductivity values. (0.017W/mK). Nansulate, when fully cured, contains approximately 70%Hydro-NM-Oxide and 30% acrylic resin and performance additive. It doesnot function as a metallic UV radiator (reflection). The nano-particlein Nansulate act to inhibit the heat flow much like traditionalinsulation.

In another embodiment the stylet or guide or introducer can have but isnot restricted to an outer or inner coating that provides for decreasedresistance or decreased friction from the tissue through which itpenetrates. This can include but is not restricted to a coating orcomposition that can include but is not restricted to aPolytetrafluoroethylene (PTFE) or fluoropolymer of tetrafluoroethyleneor a hypophillic or hydrophobic material, ultra-high-molecular-weightpolyethylene (UHMWPE) or mineral oil or molybdenum disulfide embedded asadditional lubricants in the stylet or guide or introducers matrix.

In another embodiment the stylet or guide or introducer can have but isnot restricted to a variable or non-uniform flexibility and tensilestrength within its length or width.

In another embodiment the stylet or guide or introducer can have but isnot restricted to a variable width of its wall or lumen. In one examplethe wall can be thicker proximal that distal such that the stylet orguide or introducer or catheter has the configuration or an a triangleor arrowhead that allows for easier penetration.

In another embodiment the stylet or guide or introducer can have but isnot restricted to a chamber that can be filled with a substance that caninclude a solid or liquid or gel or gas that can be filled to includebut not restricted to it being under pressure and causing the stylet orguide or introducer or catheter wall to harden or become more firm suchthat it can pierce the skin more easily. Once it has reached its targetthe chamber material can be withdrawn fully or incompletely or thenature of the material can be altered. In one example the catheter orstylet or guide or introducer chamber can be a nitenol or alloy metalthat when cooled is firm but when heated is soft and pliable andflexible.

In another embodiment the stylet or guide or introducer can be composedof but not restricted to a material to include but not restricted tomaterial such as nitenol or alloy metal that when cooled is firm butwhen heated is soft and pliable and flexible or other materials thathave variable hardness or softness under differing thermal conditionssuch as hot or cold, or electromagnetic conditions such as UV light orthe presence or absence of an electric current of a magnetic force toinclude but not restricted to Ferrofluids such as colloidal liquids madeof nanoscale ferromagnetic, or ferrimagnetic, particles suspended in acarrier fluid such as an organic solvent or water, magnetorheologicalfluids (MR fluids), nanoelectromechanical systems, magnetorheologicalfluid (MRF) refers to liquids similar to ferrofluids (FF) that solidifyin the presence of a magnetic field. These materials can contain andinclude but are not restricted to material that contain magnetite,hematite or some other compound containing iron that are small enoughfor thermal agitation to disperse them evenly within a carrier fluid,and for them to contribute to the overall magnetic response of the fluidand can include but is not restricted to the composition of a typicalferrofluid is about 5% magnetic solids, 10% surfactant and 85% carrier,by volume. In other embodiment the ferromagnetic particles can bearranged in a manner that can be circular or spiral or other geometricor non-geometric arrangements that can alter or vary the shape orfirmness or flexibility of the stylet or guide or introducer.

One of the uses for this type of stylet or guide or introducer caninclude but is not restricted to serve as a rigid penetrating device toreach the target tissue as it penetrates the skin or organs or vesselsbut then can become flexible and not damage the tissue any further whenit is changes to a non-rigid device.

The variable stiffness can include all or only one or more portions ofthe stylet or guide or introducer.

The stylet or guide or introducer can include multiple configurationsand its cross section can include a geometric or non-geometric orvariable configuration that can include but is not restricted to acurved or circle, or ellipse configuration or an angled or straight or,triangle, rectangle, pentagon, hexagon etc, configuration.

A catheter can include but is not restricted to the following.

A catheter can be include but is not restricted to a solid or hollowcylinder or tube device for use with but not restricted to percutaneousor transcutaneous or filling or being transmitted or transported in orwithin or through a hollow viscous or vascular structure or an organicor inorganic structure within or outside of the body.

In another embodiment is a catheter can be composed of a non-metallicsubstance such as but not restricted to rubber, or plastic or latex orcloth, carbon fibers or carbon-carbon fibers or or metallic substancethat can include but is not restricted to stainless steel, aluminum,iron, titanium or other ferrous materials and alloy or any combinationof these materials.

A catheter can be used for but not restricted to the transportation ofsubstances such as but not restricted to solids or liquids or gels orgases and can penetrate the skin or pass through human tissue ortransport within human tissue to include but not restricted to a hollowviscous stricture that can include but is not restricted to theesophagus, small and large intestine, stomach, colon, rectum, mouth,trachea, biliary ducts and nostrils or vascular structure that caninclude arteries and veins and lymphapics, or can stiffening the path,protect, guide, introduce, or filling the hollow of a device or needleor another catheter or any combination of uses but not restricted tothese uses.

The catheter can be made to consist of fully or partially of optimalinsulating materials or can be insulated with a material on the outsideportion of the stylet or guide or introducer, on the inside portion ofthe catheter if the catheter is hollow, a combination of inside andoutside of the stylet or guide or introducer, the catheter can becomposed of multiple metallic and non-metallic materials to include butnot restricted to good insulators and poor conductors of heat and canalso be composed of materials that can include but are not restricted toceramic materials, high aluminum ceramics (Alumina Ceramic), beryllium,fiberglass, Zirconium, High Zirconium, adhesives and nansulators,reinforced carbon-carbon fiber construction (aka carbon carbon,abbreviated C/C) is a composite material consisting of carbon fibrereinforcement in a matrix of graphite, Carbon fibre-reinforced siliconcarbide (C/SiC) is a development of pure carbon-carbon (C/SiC utilisessilicon carbide with carbon fibre, and this compound is thought to bemore durable than pure carbon-carbon), Fibrous refractory compositeinsulation (FRCI), LI-900 silica tiles, made from essentially very purequartz sand, High-temperature reusable surface insulation (HRSI),Reaction Cured Glass (RCG) of which tetrasilicide and borosilicate glassare some of several ingredients to waterproof the coatingdimethylethoxysilane is injected into the coating (densifying the tilewith tetraethyl orthosilicate (TEOS) also helps to protect the silicaand waterproof), RCC (a laminated composite material made from graphiterayon cloth and impregnated with a phenolic resin. After curing at hightemperature in an autoclave, the laminate is pyrolized to convert theresin to carbon. This is then impregnated with furfural alcohol in avacuum chamber, then cured and pyrolized again to convert the furfuralalcohol to carbon. This process is repeated three times until thedesired carbon-carbon properties are achieved the outer layers of theRCC are converted to silicon carbide. The silicon-carbide coatingprotects the carbon-carbon from oxidation.

In one embodiment the catheter can contain a diamond or zirconium tip.

Catheter with chambers that can circulate substances to form a heat sinkcan include are but not restricted to solids, liquids and gels andgasses or a vacuum. These can substances can include but are notrestricted to water, argon, nitrogen, and nitrous oxide or a vacuum.

In another embodiment the catheter have chambers that contain substancesor vacuum that are non-circulating.

These catheter can be used for additional applications where insulationis not a requirement.

In another embodiment the catheter can be coated or composed with anansulatecoating which can include but is not restricted to aninsulation technology that incorporates a nanocomposite calledHydro-NM-Oxide, a product of nanotechnology. This material is documentedas having one of the lowest measured thermal conductivity values. (0.017W/mK). Nansulate, when fully cured, contains approximately 70%Hydro-NM-Oxide and 30% acrylic resin and performance additive. It doesnot function as a metallic UV radiator (reflection). The nano-particlein Nansulate act to inhibit the heat flow much like traditionalinsulation.

In another embodiment the catheter can have but is not restricted to anouter or inner coating that provides for decreased resistance ordecreased friction from the tissue through which it penetrates. This caninclude but is not restricted to a coating or composition that caninclude but is not restricted to a Polytetrafluoroethylene (PTFE) orfluoropolymer of tetrafluoroethylene or a hypophillic or hydrophobicmaterial, ultra-high-molecular-weight polyethylene (UHMWPE) or mineraloil or molybdenum disulfide embedded as additional lubricants in thestylet or guide or introducers matrix.

In another embodiment the catheter can have but is not restricted to avariable or non-uniform flexibility and tensile strength within itslength or width.

In another embodiment the catheter can have but is not restricted to avariable width of its wall or lumen. In one example the wall can bethicker proximal that distal such that the catheter or catheter has theconfiguration or an a triangle or arrowhead that allows for easierpenetration.

In another embodiment the catheter can have but is not restricted to achamber that can be filled with a substance that can include a solid orliquid or gel or gas that can be filled to include but not restricted toit being under pressure and causing the catheter or catheter wall toharden or become more firm such that it can pierce the skin more easily.Once it has reached its target the chamber material can be withdrawnfully or incompletely or the nature of the material can be altered. Inon example the catheter or catheter chamber can be a nitenol or alloymetal that when cooled is firm but when heated is soft and pliable andflexible.

In another embodiment the catheter can be composed of but not restrictedto a material to include but not restricted to material such as nitenolor alloy metal that when cooled is firm but when heated is soft andpliable and flexible or other materials that have variable hardness orsoftness under differing thermal conditions such as hot or cold, orelectromagnetic conditions such as UV light or the presence or absenceof an electric current of a magnetic force to include but not restrictedto Ferrofluids such as colloidal liquids made of nanoscaleferromagnetic, or ferrimagnetic, particles suspended in a carrier fluidsuch as an organic solvent or water, magnetorheological fluids (MRfluids), nanoelectromechanical systems, magnetorheological fluid (MRF)refers to liquids similar to ferrofluids (FF) that solidify in thepresence of a magnetic field. These materials can contain and includebut are not restricted to material that contain magnetite, hematite orsome other compound containing iron that are small enough for thermalagitation to disperse them evenly within a carrier fluid, and for themto contribute to the overall magnetic response of the fluid and caninclude but is not restricted to the composition of a typical ferrofluidis about 5% magnetic solids, 10% surfactant and 85% carrier, by volume.In other embodiment the ferromagnetic particles can be arranged in amanner that can be circular or spiral or other geometric ornon-geometric arrangements that can alter or vary the shape or firmnessor flexibility of the stylet or guide or introducer.

One of the uses for this type of catheter can include but is notrestricted to serve as a rigid penetrating device to reach the targettissue as it penetrates the skin or organs or vessels but then canbecome flexible and not damage the tissue any further when it is changesto a non-rigid device.

The variable stiffness can include all or only one or more portions ofthe stylet or guide or introducer.

The catheter can include multiple configurations and its cross sectioncan include a geometric or non-geometric or variable configuration thatcan include but is not restricted to a curved or circle, or ellipseconfiguration or an angled or straight or, triangle, rectangle,pentagon, hexagon etc, configuration.

Combined Hyper and Hypothermic Device can include but is not restrictedto the following.

In another embodiment the Hyper and Hypothermic devices can be coupledto control the heating and cooling of tissue. In addition, the forcesand architecture responsible for cell death differ and the forces andarchitecture resistant to cell death differ.

In one embodiment alternating heating and cooling can create a synergythat can decrease both the temperature and duration required for hyperand hypothermia which can prove beneficial to the adjacent non-targetedtissue thus preserving the living tissue in the vicinity of the targetedtissue, which can include but is not restricted to the Parathyroid glandbeing the targeted tissue and the neural and vascular structuresadjacent to the Parathyroid gland being spared.

Markers and Localization Devices and Wires and filaments can include butis not restricted to the following.

Currently surgeons that remove Parathyroid gland adenomas rely onpre-surgical imaging to approximate the location of the parathyroidgland. Markers can be placed onto the skin but with flexion andextension of the neck the location of the Parathyroid gland can movedeeper within the neck relative to the skin surface. This flexion andextension occurs during anesthetic intubation and can vary from theposition that is used for diagnostic imaging and localization and skinmarker placement.

Methods for marking and localizing the Parathyroid gland can proveuseful. In one embodiment the Parathyroid gland to be removed can bepercutaneously injected into the Parathyroid gland with a markingmaterial that can include but is not restricted to a solid or liquid orgel or gas such as but not restricted to methylene blue and gentianviolet, tattoo inks, fluorescent light or UV sensitive dyes which caninclude but are not restricted to nanoparticles to include but notrestricted to Solgel derived silica is an excellent host material forcreating fluorescent nanoparticles by the inclusion of covalently-boundorganic dyes, Flourophores that can be organic or inorganic, Fluorite(also called fluorspar) is a halide mineral composed of calciumfluoride, CaF2. Gemstones, minerals, may have a distinctive fluorescenceor may fluoresce differently under short-wave ultraviolet, long-waveultraviolet, or X-rays, calcite and amber will fluoresce under shortwaveUV. Rubies, emeralds, and the Hope Diamond exhibit red fluorescenceunder short-wave UV light; diamonds also emit light under X rayradiation, Vitamin B2 (fluoresces yellow), quinine (blue), ninhydrin.And fluorescein.

In another embodiment the injected material an be metal radio-opaque andcan be viewed with x-ray and can include but are not restricted tocalcium, iodine, iron and other metals such as titanium, tungsten,barium sulphate, and zirconium oxide

In another embodiment the marker or localizing device or substance canbe a radioactive material that is low dose and used for diagnosticradiology that can include but is not restricted to Technecium 99m,Iodine 123 and Iodine131 or Sestamibi99 mTc, which can be percutaneouslyinjected directly into the Parathyroid gland. A percutaneous injectionwould have the advantage over intravenous sestamibi because of the lackof background counts in organs other than the Parathyroid gland such asthe thyroid and fatty tissue and muscles. A radiation sensitive probesuch as a pencil probe can be used to locate the Parathyroid glandduring surgery more easily.

The markers and localization devices can contain a GPS device or containa material that emits or provides for GPS detection.

To place the marker or localizing device a guide/wire/placement device,a stylet or a tube or needle or a hollow or solid tube can be used toplace the marker or localizing device in the target tissue, parathyroid.In one embodiment the marker or localizing device can contain atransitional zone that contains a transitional state sensitive substancethat can be converted from a solid or liquid/gel material that whenexposed to a substance or an energy source such as but not restricted toelectromagnetic energy, kinetic or mechanical or thermal energy orforces changes its state and can separate from the a more solid or gelstate to a state where the placement device is separated from the markeror localizing device device. In one embodiment the placement materialand the transitional material and the marker or localizing device canall be metallic and if energy such as an electrical current or a thermalforce is transmitted though the placement wire the transitional zonewill separate from the marker or localizing device. In anotherembodiment the placement device material can be composed of a phasetransitional gel that when cold remains solid but when heated thetransitional zone will melt or dissolve after a given period of time andseparate from the marker or localizing device. In another embodimentphase transitional gels or other materials that can alter the physicalstate of the gel. Solvents can be used to alter the physical state ofthe material.

The placement device can have grooves/threads that when turned or movedin the proper manner that will release/unthread. In one embodiment thegel can take on crystalline characteristics and become more rigid orless rigid when exposed to electromechanical or kinetic or mechanicalenergy such as liquid crystal (LC) gels with radial or twisted-radialmolecular orientation are fabricated using a radial electric fieldgenerated by an indium-tin-oxide hole electrode in the bottom substrate.If the top substrate is not buffed, the radial-type LC gel is formedwhich can convert linearly polarized light into axially polarized light.On the other hand, if the top substrate is homogeneously buffed, then atwisted-radial LC gel is produced which can convert linearly polarizedlight into radially polarized light. These polarization converters areuseful for diffractive optics and optical imaging systems.

The placement device can be a tube, which is hollow and can transport afilament that can be organic and include but not be restricted to silkor cotton or hemp or can be inorganic and can be composed or syntheticpolymers such as but not restricted to nylon, rayon, or a carbon orcarbon-carbon synthetic filament or a metallic filament. The filamentshould be flexible enough that it does not damage the tissue throughwhich it passes such as but not restricted to the thyroid, fat and skin.The marker or localizing device can then be attached to the filament andput in place percutaneously within the target tissue, the parathyroidgland.

In another embodiment a percutaneous localization device can be used toassist in removing a parathyroid gland. This technique is used commonlyin breast localizations but the breast tissue is composed of fat andbreast parenchyma and stromal tissue that is predominantly non-vascular.A localization device for the parathyroid will likely have to passthrough the thyroid gland, which is highly vascularized. Therefore theguide will have to be both anchor securely to the parathyroid gland andthe wire between the parathyroid to the skin will have to be bothdurable and stout and pliable.

The localizing wire material can include but is not restricted tostainless steel, nitenol, titanium, and other metals and metal alloysthat can be both Magnetic Resonance Imaging (MRI) compatible or not MRIcompatible, carbon-carbon fibers, organic and inorganic material whichcan be combined or added to create and maximize flexibility and strengthand the localization wire can be composed different segments that cancontain one or a combination of materials for each segment.

In one embodiment the wire can be composed with a transitional materialthat resides between the skin component and the target tissueparathyroid gland such that when heat or an electric current of otherelectromagnetic or mechanical or kinetic energy or force is administeredto the wire the transitional component the two segments detach ordisengage, leaving the parathyroid component of the localizing wireseparate from the percutaneous skin component.

In one preferred embodiment the wire can be composed of a carbon-carbonmatrix that is a segment that is highly flexible and a more rigidsegment that can include but is not restricted to a hook or anchor thatis embedded into or surrounds a portion or the entirety of theparathyroid gland. These segments can be composed of the same materialor different materials or a combination of materials.

The localizing device can include and be composed to include but notrestricted to a solid wire, a braided or woven wire. The localizingdevice and wire and the parathyroid anchoring component can be texturedor beaded to increase its detection with ultrasound. The localizingdevice and wire and anchor can be MRI or CT scan visible. The localizingdevice can be coated with a material that can provide for improvedimaging visualization or for insulation.

The localizing device can be can be oriented and configured from any arcbetween a 12 o'clock to 12 o'clock full 180 degree arc or rotation, theanchor can consist of one or multiple tines or projections, thelocalizing device can consist of but is not restricted to a threaded,beaded, barbed, looping, angled, curved spiral or circular or straightstructure. In one embodiment the localizing device can be screwed intoor out of the target tissue such as the parathyroid gland. In anotherembodiment the localizing device can be coated with a material that isorganic and dissolvable or which can be metabolized by the organism overtime and which can also be stripped from the localizing device by aguiding mechanism preferably percutaneous such that when the localizingdevice is implanted it fixes itself in the target tissue such as theparathyroid gland but if needed the localizing device can be removed bystripping the localizing device or the localizing devices coatingmaterial with the guiding mechanism and the stripped material can eitherbe dissolved, metabolized or can be made of an inert material that canbe left in the body without significant risk to the organism. Some ofthe coatings can include but are not restricted to proteins,carbohydrates, fats, minerals, and other organic or inorganic materials.

The localizing device can also be used for treatment if the coating thatis stripped from the localizing device is composed of a material thatcan suppress the function of the target tissue such as the parathyroidgland and can consist of but is not restricted to substances or peptidesor peptide analogs to include but not restricted to portions of theparathyroid molecule which can include the active portion of the targettissue hormonal gland such as the parathyroid molecule. For parathyroidfunction and homeostasis, molecule or minerals such as Calcium ororganic or inorganic compounds that can bind to receptors such asSestimibi, Sensapar (Cinacalcet) or Calcium analog compounds that arerelated to the parathyroid receptors can be used to the parathyroidbinding receptors and can utilize methods for reversible or irreversibleattachment.

The marker or localization device can contain a GPS device or contain amaterial that emits or provides for GPS detection.

The marker can include an LED device.

The marker or localizing device can have a shape that will pierce thetarget tissue but will offer resistance when it is attempted to removethe marker or localizing device. This can include but is not restrictedto a corrugated shape, a friction producing shape or a shape wheretarget tissue becomes embedded in the marker. The resistance can becontrolled such that it is not engaged or activated until the marker orlocalizing device lies within the target tissue, parathyroid.

Hooks

One embodiment can include hooks to secure the parathyroid gland andthese hooks can be non-heat conducting and insulated or heat conducting.The hooks can include but are not restricted to a curved single ormulti-pronged device that can exit a guiding needle or catheter and snapopen and can also return into the guiding needle or catheter.

The hook anchor can be can be oriented and configured from any arcbetween a 12 o'clock to 12 o'clock full 180 degree arc or rotation, theanchor can consist of one or multiple tines or projections, the hook canconsist of but is not restricted to a threaded, beaded, barbed, looping,angled, curved spiral or circular or straight structure. In oneembodiment the hook can be screwed into or out of the target tissue suchas the parathyroid gland. In another embodiment the hook can be coatedwith a material that is organic and dissolvable or which can bemetabolized by the organism over time and which can also be strippedfrom the hook by a guiding mechanism preferably percutaneous such thatwhen the hook is implanted it fixes itself in the target tissue such asthe parathyroid gland but if needed the hook can be removed by strippingthe hook or the hooks coating material with the guiding mechanism andthe stripped material can either be dissolved, metabolized or can bemade of an inert material that can be left in the body withoutsignificant risk to the organism. Some of the coatings can include butare not restricted to proteins, carbohydrates, fats, minerals, and otherorganic or inorganic materials.

Insulating Materials can include but is not restricted to the following.

Insulating materials can be used but are not restricted to the thermaldevices, energy delivery, cryo-devices, wires or hooks or localizationdevices, or needles, or guiding catheters or needles or electrodes orantennas and other therapy device or assisting devices and can includebut are not restricted to vacuums, circulating solids or liquids or gelsor gasses, ceramic materials, high aluminum ceramics (Alumina Ceramic),beryllium, fiberglass, Zirconium, High Zirconium, adhesives andnansulators, reinforced carbon-carbon fiber construction (akacarbon-carbon, abbreviated C/C) is a composite material consisting ofcarbon fibre reinforcement in a matrix of graphite, Carbonfibre-reinforced silicon carbide (C/SiC) is a development of purecarbon-carbon (C/SiC utilises silicon carbide with carbon fibre, andthis compound is thought to be more durable than pure carbon-carbon),Fibrous refractory composite insulation (FRCI), LI-900 silica tiles,made from essentially very pure quartz sand, High-temperature reusablesurface insulation (HRSI), Reaction Cured Glass (RCG) of whichtetrasilicide and borosilicate glass are some of several ingredients towaterproof the coating dimethylethoxysilane is injected into the coating(densifying the tile with tetraethyl orthosilicate (TEOS) also helps toprotect the silica and waterproof), RCC (a laminated composite materialmade from graphite rayon cloth and impregnated with a phenolic resin.After curing at high temperature in an autoclave, the laminate ispyrolized to convert the resin to carbon. This is then impregnated withfurfural alcohol in a vacuum chamber, then cured and pyrolized again toconvert the furfural alcohol to carbon. This process is repeated threetimes until the desired carbon-carbon properties are achieved the outerlayers of the RCC are converted to silicon carbide. The silicon-carbidecoating protects the carbon-carbon from oxidation.

Combination and Multiple Devices can be used and can include but is notrestricted to the following.

In another embodiment multiple devices can be combined to include butnot restricted to hyperthermic devices, hypothermic devices, mechanicaldevices, substance delivery such as through a hollow bore needle,sensory feedback devices and local environment therapy delivery.

A Display Screen and/or Protective goggles can include but are notrestricted to the following.

A viewing screen 105 that can be created to move with and/or track withthe viewers eyes or head or body and in one embodiment can include butis not restricted to glasses/goggle/mask 105 that can serve as but isnot restricted to a display, screen or visual representation 110, 102.The visual representation can but are not restricted to display theimages 102 or data 104 from an imaging device/s 5 or the treatmentdevice/s 75 or diagnostic devices 81. Imaging sources can includeimaging from but not restricted to ultrasound, MRI, CT scans, thermal orlaser imaging. Data sources can include but are not restricted to energy100 deposition, dimensional data such as length and width and depth,temporal data, devices engaged and sensory feedback 31. The data can betransmitted by hard-wiring 107 such as but not restricted to cables andfiberoptics and metal wires or by non-wire sources 103 such as but notrestricted to WI-FI. In addition, the display 105 can have the form ofglasses/goggle/mask 105 that can also protect a portion of the body orface from in one embodiment the viewers face or portions of the face 109from energy 100 or substances 99 that can include but are not restrictedto organic or inorganic substances 99 or energy 100. In one embodimentthe protective device 105 and the viewing device 105 can be combined orcan be separate and can contain unique protections such as but notrestricted to electromagnetic or thermal protections 43. In anotherembodiment the protective device 105 and/or the viewing device 105 canincorporate a seal 112 that can be airtight or watertight or can bebreathable and non-airtight or watertight. The display can be worn on aportion of the body 107 that can include the face and can be worn like ahelmet of pair of glasses or goggle. In another embodiment it can beworn and extend from another portion of the body such as the shouldersor torso or a combination of body parts. A portion or all of thedisplay/screen/goggles/glasses 105. can be opaque, transparent ortranslucent.

Organism can include but is not restricted to the following.

These methods and procedures and uses and devices can be used for and onand with human and non-human organisms.

One method for treating the parathyroid gland includes the use ofnon-invasive techniques to include but not restricted to transdermalHIFU and electromagnetic focused energy treatments.

Another method for treating the parathyroid gland includes the use ofminimally invasive techniques to include but not restricted topercutaneous techniques that can include but are not restricted to MW,HIFU, RF, radioactivity, hot and cold lasers. Medication delivery toinclude but not restricted to sclerotherapy, electromagnetic energy andmechanical energy.

A further object is to provide methods to ablate and control theparathyroid glands while preserving, or minimally damaging, adjacentanatomical structures, including vital organs and cellular tissue,nerves and vessels. In one embodiment, various medications,radiofrequency (RF) devices and systems, as well as various therapeuticultrasound devices and systems can be used alone or together for thenon-invasive or minimally invasive ablation of parathyroid glands areprovided.

Another method for preserving local tissue while treating theparathyroid gland can include sensitizing the parathyroid gland ordesensitizing the local tissue with medication and then subjecting theparathyroid gland to electromagnetic energy that preferentially treatsthe parathyroid gland and preserves the adjacent anatomic structures.

Another object of the present invention involves the application ofenergy or medication or a combination of both to one or more parathyroidglands to reduce or promote or induce increased or decreased activity ofthe treated parathyroid gland as a means for regulating a patient'shormone and calcium levels and osteoporosis this can include but is notrestricted to placing pacer wires on the parathyroid gland, placing acatheter in the parathyroid gland that can increase or decrease bloodsupply to and from the parathyroid and thus alter the sensitivity of theparathyroid hormone release and production.

Another embodiment includes the localization of the parathyroid glandfor surgery or for non-surgical treatment. One method can include but isnot restricted to the percutaneous placement of an RF device, a GPSdevice or a combination of both for tracing the location of an organ toinclude but not restricted to the parathyroid gland. In another methodthe percutaneous placement of an electromagnetic energy source, such asa radiopharmaceutical which can include but is not restricted to FreeTechnecium or Technecium bound to Sestamibi or other nucleotides toinclude but not restricted to I-123 or I-131, onto or near the targetorgan can then be localized using a device to include but not restrictedto a radioactivity detector such as but not restricted to a pencil probeGeiger counter. In another method the radioactivity can be combined withanother imaging device which can include but is not restricted to aSPECT-CT or a SPECT-MRI or a PET-CT. This technique can be used todirect treatment to an organic structure that can include but is notrestricted to the parathyroid gland.

Throughout this disclosure the term “treatment” can include activation,deactivation, modulation, and destruction of organic or inorganicmaterial. Energy can include any suitable form of energy, includingradiofrequency ablation (RF) and microwave (MW) and laser (L),Cryotherapy (CryT), Hight Intensity Focused Ultrasound (HIFU),Radioactive Therapy (Brachytherapy: BrT), Irreversible Electroporation(IRE), Electrical Current Therapies, Electrocautery, Magnetic Resonance(MR), Ultrasound, (US). A deactivating solution is one that diminishesor stops treatment; an activating substance initiates, augments, orcontinues treatment; and a neutralizing substance is one thatneutralizes treatments or eliminates conditions under which treatmentmay occur. Specific examples are given throughout without loss ofgenerality. One example of this is a disclosure that dextrose water canbe delivered via a thermal probe; however, this disclosure is notlimited to the use of a thermal probe. Other suitable means ofdelivering dextrose water are also disclosed.

Throughout this disclosure the following terms are non-exclusivelydefined as follows. A sheath can include but is not restricted to a tubeor conduit or guide or guide that may be hollow or solid. A member caninclude but is not restricted to a tube, cylinder, probe wire, guidewire, guide, device and it can be solid or hollow. A controller caninclude but is not restricted to a device that takes an action inresponse to an input. A measuring device can include but is notrestricted to a sensor, or a device to measure a quality or quantity ofa substance or energy or a phenomenon or a biological event. Abiological function can include but is not restricted parathyroidhormone activity, temperature, calcium levels, ionizing calcium,electrolytes, local temperature around parathyroid, neuronal function(laryngeal nerves), larynx and innervation, respiratory function,sympathetic and parasympathetic (primary and secondary) function,arterial flow, venal flow, brain function, cardiac functions, bloodpressure, chromography, and vital and hormonal and physiologicmeasurements, signs and symptoms. Placement of a needle can include butis not restricted to placement by at least one organism with or withoutrobotic assistance. The energy delivered and the insulation experiencedat any given moment during treatment by the user's target and non-targettissue can both vary and can be variable to include but not restrictedto duration, direction, exposure, periodicity or frequency. Thetechniques and methods in this disclosure can be applied to humans ornon-human organisms. An inhibitor is an energy or substance that canalter, modulate, control, activate, deactivate, or neutralize an energyor a substance and can include but is not restricted to thermal energywhere an RF device and the heat produced can be inhibited by a cold orcooled liquid or gel in the vicinity or perimeter tissue or targettissue; or cold from a cryoprobe device can be inhibited by a heatedliquid or gel or by an RF device that warms the tissue; or radioactivityfrom brachytherapy is inhibited by lead or other elements that restrictradioactivity; or a laser device where the electromagnetic light energyis inhibited by an opaque or translucent or semi-opaque material; or anRF device that where the RF transmission and penetration or inhibited bya substance that inhibits RF transmission and can include but is notrestricted to Dextrose water or a hydrogel or a low or non-osmolar ornon-ionic compound; or an electrical current that is inhibited by asubstance that prevents electrical transmission that can include but isnot restricted to a non-ionic or low or non-osmolar substance; an acidthat can be inhibited by a base or a base that can be inhibited by anacid; a sclerosant such as ethanol or sotradecol that can be inhibitedby dilution by saline or water; a carboxylated molecule that can beinhibited by a decarboxylating enzyme or substance; a wavelength thatcan be inhibited by a wavelength with a wavelength that is has afrequency and amplitude and periodicity that inhibits the primary or thesecondary wavelengths produced that can include but is not restricted toa second wavelength that is the mirror or the first wavelength; a phasealtering substance that can metamorphasize from a liquid to a gel andcan capture a substance can include but is not restricted to an enzymeor anti-angiogenic compound that can be injected into the target tissueand if it leaks out of the target tissue can then captured andneutralize or inhibited or denatured; an adhesive that can bedeactivated by UV light; the inhibitor can be at least one energy or asubstance that inhibits the treating energy or a substance. A hormone inits classic definition refers to a chemical which can be released by acell or a gland in one part of the body that sends out signals ormessages or information that can affect cells or tissue or function inother parts of an organism. A hormone can include but is not restrictedto an organic or inorganic substance or molecule that can include but isnot restricted to a biological substance that can be produced in anorganism from endocrine or exocrine glands, or from biological tissuethat can be ectodermal, mesodermal or endodermal and which can becomposed of or from but not restricted to any combination of organicsubstances such as but not restricted to a peptide, a protein, a fat, acarbohydrate, or a steroid, and examples can include but are notrestricted to parathyroid hormone, insulin, gastrin, testosterone,estrogen, follicle stimulating hormone, growth hormone, prolactin; andthe hormone can include inorganic substances that can include but notrestricted to a mineral that can include but is not restricted toCalcium, Zinc, Iron or Magnesium and said hormone can exhibit or produceor exert or influence an effect on both local and distance tissue withinthe organism.

DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENT

Preferred and alternative examples of the present invention aredescribed in detail below with reference to the following drawings:

FIG. 1 is a frontal view, anatomic rendering of the thyroid andparathyroid glands in the anterior mid neck. There are two thyroidlobes, which include the right lobe of thyroid 25 and the left lobe ofthyroid 22 and the isthmus of the thyroid 18. Any portion of the thyroidgland or tissue can be referred to as thyroid gland or tissue 20. Thereare four parathyroid glands, which include the right superiorparathyroid gland 10; the right inferior parathyroid gland 14; the leftsuperior parathyroid gland 12; and the left inferior parathyroid gland16 or an ectopic parathyroid gland 15 any individual parathyroid glandor parathyroid tissue 10 can be referred to include but not restrictedto a normal parathyroid gland or a parathyroid adenoma, hyperplasia,carcinoma or normal functioning or hypo-functioning or hyper-functioningparathyroid gland in a typical or an atypical, ectopic, location. Anerve 19 is depicted on the right specifically the Recurrent LaryngealNerve, but there are numerous nerves 19 bilaterally including theinnervating sympathetic and parasympathetic nerves as well as thetraversing Laryngeal Nerves 13 and the Vagus nerve 21, which reside nearor in the vicinity 17 of the parathyroid glands 30. The thyroid 20 andparathyroid 30 reside within the neck 03 and are beneath the skin'ssurface 6 and are subcutaneous tissue 92. Treatment devices 80 andimaging devices 5 can be placed on the skin 6 (shown), or through theskin 90 percutaneously (not shown) or non-percutaneously such as but notrestricted to transcutaneously (not shown) in order to treat and orvisualize the target organs, specifically the parathyroid 30 and theparathyroid tissue 30. Thyroid gland tissue shall generically bereferred to as 20 and Parathyroid tissue or gland shall generically bereferred to as 30.

FIG. 2 is an isolated parathyroid gland 30 that can represent but is notrestricted to a normal parathyroid gland, an enlarged normal gland, ahyperplasic gland, an adenomatous gland and/or a hyper- or hypo ornormally functioning functioning gland 30 of the parathyroid 30 or acarcinoma 30. There are arterial blood vessels that create inflow 32 andveins 34 that provide outflow of blood from the parathyroid gland 30.The innervating nerves 19 of the parathyroid 30 are depicted. There istissue that surrounds or is in the vicinity 17 of the parathyroid gland30

FIG. 3 is a rendering of a device 58 that can be used to penetrate theskin 90 and the subcutaneous tissue 92 to reach the parathyroid gland30. In this embodiment the penetrating device is configured as a needle,which is pointed or cutting or piercing tip 116 and has a guiding device50, which can include but is not restricted to a sheath or catheter thatallows repetitive access to the parathyroid tissue 30.

FIG. 4 is a rendering of a guiding device 50 with a blunt end 61 but notrestricted to a blunt end. Inside of the guiding device 50 is atube/conduit 52 that can have one 54 or more than one channel 56 for theintroduction of substance 99 to include but not restricted to solids 76,liquids 78 or gasses 77 (not shown).

FIG. 5 is a rendering of a guiding device 50 penetrating the parathyroidtissue 30. There is tube 52, which provides for the passage ofsubstances 99 to include but not restricted to solids 76, liquids/gels78 or gases 77 (not shown). The tube/conduit 52 is in proximity to theparathyroid tissue 30 the artery 32 the nerve 19 and the vein 34. Thetube/conduit 52 can include but is not restricted to a needle, catheter,or a delivery device. In one embodiment the guide 50, tube/conduit 52can be a needle 52 can have but is not restricted to having a groove ormechanical thread configuration 66 that penetrates the parathyroid 30with a screw-like motion or mechanism. The threads/grooves 66 can be onthe inside or the outside or be integral to the structure of all or aportion of the tube 52, such as but not restricted to the distal aspect51 of the tube 52.

FIG. 6 is a rendering of a guiding sheath 50 penetrating the parathyroidgland 30. There can be an additional tube 52, which provides for thepassage of substances 99 such as solid 76 or liquid 78 or gas 77material(s) and can serve multiple functions to include but notrestricted to insulation for the local tissue. The tube/conduit 52 is inproximity or can be penetrating the parathyroid tissue 30) the artery 32and the vein or nerve (not shown). The solid device/probe/member 75 canhave multiple uses that include but are not restricted to treatment,localization and visualization of the parathyroid 30. Treatment device75 can include but is not restricted to the delivery of energy 100 suchas but not restricted to electromagnetic energy or mechanical energy orheat or cold and the viewing or visualizing device 75,81 can include butis not restricted to a fiberoptic or thermal viewing device. Traversingor being transported through the tube/conduit 52 can be a soliddevice/probe/member 75 that can be used to partially or fully ablate theparathyroid tissue 30 or selectively the parathyroid arteries 32 orveins or nerves (not shown).

FIG. 7 is a rendering of a guiding device 50 penetrating the parathyroidtissue 30. There can be an additional tube 52, which provides for thepassage of a substance 99 to include but not restricted to a substanceto include but not restricted to solids 76, liquids/gels 78 or gases 77material(s) and can serve multiple functions to include but notrestricted to insulation. The tube 52 is in proximity to the parathyroidtissue 30 the artery 32 and the vein 34. Traversing the tube/conduit 52can be a hollow or solid device 75 that can be used to partially orfully ablate the parathyroid 30 or the parathyroid arteries 32 or veins34 or nerves 19 (not shown) that can deliver one or any combination ofsubstances 99, solids 76, liquids 78 or gasses 77.

FIG. 8 is a rendering of one embodiment of a transcutaneous imaging 5and or energy delivery device 80 for ablating one or more parathyroidglands 30. The energy transcutaneous delivery device 80 delivers energy100 through the skin 90 through the subcutaneous tissue 92 and thetarget organ 1, the parathyroid gland 30 can be imaged with atranscutaneous imaging device 5 to ablate parathyroid tissue 30preferably while the surrounding tissues 17, anatomical structures(including, e.g., nerves 19, vessels 32, 34, thyroids 20) are preserved.In one possible embodiment, the transutaneous energy delivery device 80can include but is not restricted to HIFU (is deliverable though atranscutaneous device 80 allowing for the MIT, TTMIT, or non-invasive,ablation of the parathyroid glands 30. In this embodiment the device 80uses energy 100 which can be electromagnetic or chemical or kineticenergy 100 for either diagnostic or therapeutic purposes. The treatmentdevice 80 can be coupled with a diagnostic device 5 or the treatment andthe diagnostic devices that are combined 7 or are not combined. Theenergy 100 is directed at the target tissue to include but notrestricted to the parathyroid 30 and can be directed toward its vascularsupply including the arteries 32, veins 34 (not shown) and the nerves19. The electromagnetic energy can pass through the skin 90 andsubcutaneous tissue 92. A tube or conduit 52, which can contain one 54or more 56 channels can be placed through the transcutaneous imaging 5or treatment device 80 and within the tube/conduit 52 can be anadditional tube 52, which can be solid or hollow and can be used fordelivery of a substance 99 or energy 100 or can be used for stability orguidance can be or contain a device 75 that can deliver additionalsubstances 99 or energy 100 to the target tissue 1, the parathyroidgland 30. The tube/conduit 52 can include and can refer to a but is notrestricted to a needle 58, a stylet 57, a sheath 59, a hook 60, a guidewire 70 a guide sheath 50, a treatment delivery device 75, a sensor 31,a probe 94, or a percutaneous diagnostic device 81. The term tube 52 orconduit 52 can be used interchangeably and can relate both to a tube 52or conduit 52 that can be solid or hollow or a combination of solid andhollow and can contain one 54 or more channels 56. It is recognized thata conduit more often can imply a tube that is hollow and can transport asubstance 99 or energy 100 and that a tube can generically refer to anobject that can be either solid or hollow or a combination of these twoelements.

FIG. 9 is a rendering of a transcutaneous device 80, 5 that useselectromagnetic or mechanical or kinetic, which can include but is notrestricted to motion and heat thermal energy 100 for either diagnosticand imaging and visualization or therapeutic purposes. The energy 100 isdirected at the target tissue to include but not restricted to theparathyroid 30 and can be directed toward its vascular supply which caninclude the arteries 32, the veins (not shown) or the nerves 19. Theelectromagnetic or mechanical or kinetic energy 100 can pass through theskin 6, 90 and subcutaneous tissue 92. A delivery tube 52 needle 58 orimaging or treatment device 75 can penetrate the skin 6, 90 andsubcutaneous tissue 92 to reach and can penetrate the target tissue toinclude but not restricted to the parathyroid 30 and its vascular supply32, and nerves to treat the parathyroid gland 30. A solid 76, liquid 78or a gas 77 substance 99 or a combination of these substances can bedelivered to the parathyroid 30. In one embodiment the guidance of theneedle 28, 52 and substance placement is visualized or measured by thecutaneous 5 imaging device 80 that can include but is not restricted toan ultrasound, MR, CT, laser or thermal imager. In another embodimentthe device 80 can activate or can deactivate the solid 76, liquid 78 ora gas 77 substance 99. One or more than one device 80 or delivery tube52 needle 58 or imaging or treatment device 5, 80(shown), 75, 81 can beused and one or more than one form of energy 100 can be used alone or inmultiple combinations. The local tissue 17 and the subcutaneous tissue92 and nerves 19 can be protected from the delivery of energy 82 or nonenergetic methods or substances and can be delivered by multiple methodsto include but not restricted to a delivery tube 52 needle 58 or imagingor treatment device 75 to protect the local tissue 17 in the vicinity ofthe target tissue parathyroid 30. A sensor 31 can be used to monitor thelocal vicinity non-target tissue 17 or the target tissue 1,30 (notshown).

FIG. 10 is a sagittal cross-sectional rendering of the thyroid 20 and anormal superior parathyroid gland 30 and an abnormal inferiorparathyroid gland 30. The trachea 46 lies adjacent to and posterior tothe thyroid 20 and the two parathyroid glands 30. The RecurrentLaryngeal Nerve 13 which innervates the Larynx 47 and the local nontarget vicinity tissue 17 and organs 46, 15 and nerves 19 can bemonitored 31 or protected from the ablative substances or energetic ornon-energetic methods delivered to the parathyroid gland 30 and thedelivery can include but is not restricted to a tube or conduit 52,needle 58 or imaging or treatment device 75. A sensing device 31 caninclude or not include a sensor sensitive to the delivery device 31output to inslude but not restricted to electromagnetic energy orkinetic or mechanical energy 100 that can include thermal or light orelectrical measurements to include but not restricted to resistance(ohms) voltage or amperage and said sensor device 31 information andfeedback can be used to protect the non-target vicinity tissue 17 anddetermine the treatment to the target tissue 1, 30.

FIG. 11 is a tube or conduit 52, needle 58 for percutanuously depositinga substance/s 99 to include but not restricted to solids 76,liquids/gels 78 or gases 77 material(s), which in the preferredembodiment can include in one embodiment a standard radioactive seed 63,a radioactive bead 64 that can measure less than or equal to 1 mm or canbe greater than 1 mm or in another embodiment a biodegradable colloidradioactive 65 for brachytherapy. In one embodiment there is a stylet57, which fits into the hollow needle and in one embodiment governorscan be locking or non-locking and can serve as a delimeter and/orguiding mechanisms 66 can include but is not restricted to matchingtreads 53 or ruts, grooves 66 or locking delimeters or governors 67 orcan be without these governors 67 or can be a combination or theseelements such that the stylet can be screwed down or be rotated 36 oradvanced 68 into position and can lock and unlock. The stylet 57 andtube/conduit 52 or needle 58 together can have a delimiter or governorthat limits the distance or motion traveled by the stylet 57 and whichcan adjust to position or seat the treatment substance 99, orbrachytherapy 63, 64, 65 into position within the parathyroid gland 30.A stylet 57 and tube/conduit 52 or needle 58 or device delivery 75 withgovernors and locking and guiding mechanisms 66 can be used fornon-brachytherapy treatment and visualization systems.

FIG. 12 is an example of an energy device 75 that can utilize but is notrestricted to electromagnetic or kinetic or thermal or mechanical energyor methods and that is composed of an elongated member that can includebut is not restricted to a distal component where the treatment isdelivered and a more mid component an proximal component that isinsulated 43 or where a tube/conduit 52, guiding sheath 50 can beinsulated 43.

The device can penetrate the target tissue, parathyroid gland 30 anddeliver the treatment in a manner that protects the local vicinitytissue 17. The treatment device 75 can pierce the skin 90 andsubcutaneous tissue 92 in a percutaneuos manner in order to deliver thetreatment. This can be combined with transcutaneous treatment 80 orimaging device 81 that can include but is not restricted to diagnosticultrasound and MR and thermography and CT or a percutaneous imagingdevice to include but not restricted to a fiberoptic or laproscopic orlaser imaging device in order to define the target tissue, parathyroidgland 30. The energy delivery device 75 can be coupled to energygenerator 23. In this embodiment, the energy delivery device 75 and theenergy generator 23 can be coupled together and can receive feedback orinformation from a sensing device 31 that can be integrated into themember of the energy delivery device 75 or the sensor can be separatefrom the energy delivery device and can lie in or near the parathyroid30 or in the vicinity non-target tissue 17 and the sensor 31 can serveas a controller of the treatment.

FIG. 13 is an embodiment of a tube/conduit 52 or needle 58 or guidingsheath 50 that can include one channel/lumen 54 or more than one channelor lumen 56 that extend through at least a portion, or the entirelength, of the tube/conduit 52 or needle 58 and can contain one or morechannels. One or more channels can be configured as pathways used forthe delivery of solids 76, liquids, gels 78 or gasses 77. Channels 54,56 can be used for localization/visualization of tissue 30 or treatmentor a combination of either or both localization/visualization ortreatment and permit the passage or transport of substances 99 ordevices 75, 31, 81 to treat the target tissue parathyroid gland 30 andmonitor with a sensor 31 and protect the vicinity non target tissue 17with a substance 99.

FIG. 14 is an embodiment of a percutaneous device 75 and a guiding tube50 that can combine hot thermal 98 and cold thermal 96 energy fortreatment. The combination of differing thermal elements can be switchedon and off to control the precise temperature, which can include asensing device 31.

FIG. 15 a is an embodiment of an energy delivery device 75 to includebut not restricted to a laser, RF, or microwave probe that can have anenergy 100 delivery device probe component 94 and an insulating 43component that can be fixed or not fixed. In this embodiment aninsulated 43 guiding tube/conduit 50 can also assist in altering theenergy delivery.

FIG. 15 b is an embodiment where the relationship of the energy deliverydevice 75 or probe component 94 and the insulating component 43 and theguide 50 are not fixed and the treatment device 50 can beadvanced/retracted 68 or rotated 36 relative to the insulation 43 andthe guide 50 or any combination of movements of the insulation or theguide or the treatment device relative to the each other.

In FIG. 15 c one embodiment can include a laser treatment device 75 andtwo conduits 52 that are insulated 43 that contain openings orfenestrations 37 that can include but are not restricted to slits orholes 37 that serve as fenestrations 37 or windows 37 to the laserlight. When the conduit fenestrations 37 are not aligned the amount oflight or heat escaping the two conduits 52 and reaching the targettissue 30, 1 (not shown) is more limited than when the fenestrations 37are aligned. In one embodiment the two tubes/conduits 52 can beconfigured in a logarithmic pattern with strategic cut-outs that can bemoved-linearly 68 or rotated 36.

FIG. 16 is an embodiment in which the target tissue, parathyroid gland30, contains percutaneously place a treatment device 75 and atube/conduit/catheter 52 or needle 58 can treat the local vicinitytissue 17 with a substance 99 or energy 100, which can include but isnot restricted thermal cold 96 or heat 98. Either with or without theactual treatment of the vicinity tissue with thermal cold 96 or heat 98,the instillation of a cold 96 or body temperature or heated 98 substancesuch as but not restricted to a liquid 78 such as but not restricted todextrose water this method can act as a heat-sink to protect the localvicinity tissue 17.

FIGS. 17 a and b are a simplified diagram of the zone of ablation. Thetreatment device is placed into the target tissue 1, 30 and a centralarea adjacent to the probe 94 or treatment device 75 causes irreversibleablation 38. In the MIT there are multiple zones of ablation that are ofintermediate or partial damage to the vicinity tissue 17 beyond thetarget tissue 1, 30 and extending into the vicinity or local non-targettissue 17. With TTMIT the energy deposition 100 or the substancedeposition 99 (not shown) or the local protective treatment (not shown)are designed to reduce the vicinity or local non-target tissue 17 to asminimal an area as possible even possible at the reduced effectivenessof the treatment of the target tissue 30,1. In FIG. 17 a the zone ofirreversible ablation 38 affects both the parathyroid 30 target tissue 1and the vicinity tissue 17. In FIG. 17 b only the parathyroid 30 targettissue 1 is affect and the parathyroid tissue may even be incompletelyablated 38 but the vicinity tissue 17 is partially or completely sparedfrom ablation 38.

FIG. 18 a is an embodiment of one probe or device or FIG. 18 b multipleprobes within the target tissue 1 parathyroid gland. This embodiment caninclude one or more probes and is dependent on the size of the targettissue 1, parathyroid gland 30 that is being treated and on thetreatment device being used. In one embodiment such as but notrestricted to Irreversible Electroporation (IRE) two or moreelectrodes/probes/members/tines 75, 94 are utilized and theelectromagnetic energy, current, is transmitted between theseelectrodes/probes/members/tines 75, 94. Since IRE does not effectivelycoagulate blood vessels a second treatment modality and device 75 suchas but not restricted to electro-cautery may be needed to coagulate theblood vessels such as the arteries 32 and veins 34.

FIG. 19 a is a depiction of the temperatures of heating and theirdestructive nature. This can be altered by the duration of time that thetarget tissue 1, 30 is exposed to these temperatures. In parathyroidgland 30 treatment, the optimal temperature and duration of exposure andthe number of pulses differs from malignant tissue ablation since theacceptable percentage of cell cytolysis can be less with the FIG. 19 bbenign parathyroid 30 adenomas than with FIG. 19 c a malignant tumortissue. The zone of local vicinity tissue 17 exposures and risks fordamage to that tissue from treatment of a malignant tumor is greaterwith the malignant tumor tissue than the benign tissue because thebenign target tissue treatment can thus be directed and orchestrated tooptimize the safety of local vicinity tissue 17 compared to targettissue 1, 30 because it is less necessary/critical to achieve high killrates in the benign tissue compared to the malignant tissue especiallywith a single treatment. In one embodiment example the parathyroid gland30 cytolysis is 70% and heating is 70 degrees C. for 10 minutes with 3pulses and the local vicinity tissue damage is 1% wheresas with thetumor the target tissue 1 for the malignant tumor killing is 99% and thetemperature is 100 degrees C. for 10 minutes with 3 pulses but the localvicinity tissue damage is 30% or greater. This will vary depending onthe size of the parathyroid gland 30 adenoma and its vicinity tocritical local tissue 17 and the modality chosen to treat theparathyroid 30 adenoma.

FIG. 19 a is a simplified temperature scale depicting that atapproximately 46 degree to 56 degrees Celsius biological tissue beginsto experience lethal thermal effects and sensitivity to cell death atequal or higher temperatures. At approximately 0 degrees Celsius orlower biological tissue begins to experience lethal thermal effects 108and sensitivity to cell death at equal or lower temperatures.

FIG. 19 b depicts the pararthyroid gland 30 target tissue 1 that istreated with TTMIT such that the parathyroid gland has 90% ablation 38and the ablation 38 remains within the parathyroid gland 30 and thetreatment can be effective and reduces the parathyroid gland 30 hormoneelevated levels.

FIG. 19 c depicts a tumor 109 target tissue 1 that is treated with MITsuch that the tumor 109 to be fully treated or ablated 38 must include a5-10% rim 110 of normal adjacent tissue 17 in order to have a reasonablepossibility that the tumor has been ablated 38. To achieve this degreeof ablation 38 and effective treatment this results in additionalcollateral damage to additional vicinity or local tissue 17 beyond thetarget tissue 109, 1 and beyond the 5-10% zone or rim 111, 17 around thetumor 109,1. In the treatment of a parathyroid adenoma 30 this form ofMIT treatment would damage the local vicinity tissue such asnon-parathyroid tissue such as but not restricted to arteries 32, veins34 and nerves 19 and the trachea 46 and larynx 47.

FIG. 20 is a delivery device that can include but is not restricted to atube/catheter or conduit 52, needle 58 or guide 50 that can havesideholes 35 of variable size that can be greater in diameter proximalthan distal or greater in diameter distal than proximal or anycombination of sizes of sideholes. In one embodiment the objective isfor the sieholes 35 to be greater diameter distally and smallerproximally such that if a substance 99 that can include a liquid istransported in the conduit 52 there will be more resistance to theproximal sidehole 35 than the distal sideholes 35 for the egress of theliquid/gel out of the conduit 52. In another embodiment the sideholes 35can be larger proximally to bath the local non-target tissue 17 withliquid/gel 77 or gas 77 and not deliver as much liquid/gel 77 or gas 77to the target tissue 1, parathyroid gland 30. The substance can includebut is not restricted to a solid 76 or liquid/gel 77 or gas 77. The endof the tube/conduit 52 can be open or closed. One use of thisconduit/tube 52 with variable sideholes 35 can be to deliver variableamounts of substance 99 or energy 100 to the tissue adjacent to theconduit/tube 52.

FIG. 21 a is a tube or catheter or conduit, needle or guide, which canhave a variable sized distal end hole or the end of a conduit can beclosed and contain no end-hole and be closed at the distal end. Theconduits can be partially or fully composed of insulation and theinsulation can include but is not restricted to insulation fromelectromagnetic, thermal, kinetic or mechanical forces or energy. In oneembodiment a laser energy delivery device can reside within an insulatortube/catheter or conduit which can have a variable sized holes and canmodulate or alter the lasers effect upon the target tissue, includingthe parathyroid gland. In FIG. 21 b in one embodiment there can useside-holes or fenestrations that can be of variable size and shapeincluding geometric and non-geometric and logarithmic and logarithmicpaper shapes or cut-outs on a logarimthic pattern an can include one ormore than one a tube/catheter or conduit, needle or guide, which canhave a variable sized distal hole and a guide or sheath that is closedat the distal end and these insulating tubes or conduits can move orrotate to expose greater or lesser amounts of the energy treatment orsubstance for treatment to the target tissue, parathyroid gland. Thisembodiment can include a laser treatment device and two conduits thatcontain openings that can include but are not restricted to slits orholes that serve as fenestrations or windows to the laser light. Whenthe conduit fenestrations are not aligned the amount of light or heatescaping the two conduits and reaching the target tissue is more limitedthan when the fenestrations are aligned. This can also be organized on alogarithmic graph pattern with cut out slits that can tightly controlthe amount of light that is emitted to the target tissue. Atube/catheter or conduit 52, needle 58 or guide 50, which can have avariable sized distal hole or a sheath 59 closed at the distal end. Theinsulation 43 can include but is not restricted to insulation fromelectromagnetic, thermal, kinetic or mechanical forces or energy. In oneembodiment a laser energy delivery device 75 can reside within aninsulator 43 tube/catheter or conduit 52, needle 58 or guide 50, whichcan have a variable sized distal hole or a sheath 59 closed at thedistal end and the insulator 43 can modulate or alter the lasers effectupon the target tissue 1, including the parathyroid gland 30. In FIG. 21b in one embodiment this can be done using sideholes 35 that can be ofvariable size and shape including geometric and non-geometric andlogarithmic and logarithmic paper shapes or cut-outs on a logarimthicpattern 61. One or more than one a tube/catheter or conduit 52, needle58 or guide 50, which can have a variable sized distal hole or a sheath59 closed at the distal end 51 can be used and an insulating 43 devicecan move or rotate to expose greater or lesser amounts of the energy 100or substance 99 treatment to the target tissue 1, parathyroid gland 30.

FIG. 22 is a treatment device that delivers a substance 99 to the targettissue 1, the parathyroid or the vicinity tissue 17. The treatmentdevice 75 can deliver energy and can include a tube or conduit 52 thatcan include but is not restricted to a needle 58 or a hollowtube/conduit 52 that can include hole 35 such as sidehole or endholesthat can deliver a substance 99 to the parathyroid 99, target tissue 1or the vicinity tissue 17. The substance 99 is a substance can modulatethe function of the target tissue 1, the parathyroid 30 can include butis not restricted to peptides or peptide analogs to include but notrestricted to portions of the parathyroid molecule which can include theactive portion of the molecule or minerals such as Calcium or organic orinorganic compounds that can bind to receptors such as Sensapar(Cinacalcet), Sestimibi or Calcium analog compounds that are related tothe parathyroid receptors that are the biological component that caninclude but are not restricted to the partial or the full parathyroidhormone or an added component as needed that can be used on theparathyroid binding receptors and can utilize methods for reversible orirreversible attachments. The delivery of the energy 100 or substance 99can be performed manually or can include but is not restricted to adelivery device 114 that can include but is not restricted to contain asensory controlling device that receives feedback from the organism'starget gland 1, the parathyroid 30 or from the organism's blood or otherorgans or structures that contain biological feedback information with asensor 31 that responds the physiologic nature of the organism (notshown) to include but not restricted to the blood calcium or ionizecalcium levels or parathyroid levels and the delivery device 114 caninclude a pump 115 that can include a reservoir 112 and can include anenergy generator 23 that can include but is not restricted toelectromagnetic, mechanical, thermal, and kinetic energy In oneembodiment if the parathyroid levels in the blood increase then asubstance 99 such as but not restricted to calcium, Sestimibi, Sensapar(Cinacalcet) or calcium can be delivered to the tissue target 1, theparathyroid 30.

FIG. 23 a is a target tissue marker or localizing device that can beused to include but not restricted to a surgical marker or localizingdevice, a percutaneous treatment marker or localizing device or atranscutaneous treatment marker or localizing device. The marker orlocalizing device can consist of a substance solid or liquid or gel orgas such as but not restricted to methylene blue and gentian violet,tattoo inks. In FIG. 23 b is a fluorescent or UV sensitive dyes, orfluorescein or in FIG. 23 c an injected material can be metal or aradio-opaque material or FIG. 23 d radioactive material or in FIG. 23 eGPS device or an FIG. 23 f LED device. The marker or localizing devicecan be constructed to screw into the target tissue. FIG. 23 is a targettissue 1, parathyroid 30 marker/localizing device 40 that can be used toinclude but not restricted to a surgical marker/localizing device, apercutaneous treatment marker/localizing device or a transcutaneoustreatment marker/localizing device. The marker/localizing device 40 canconsist of a substance 99 solid or liquid or gel or gas such as but notrestricted to methylene blue and gentian violet, tattoo inks,fluorescent light or UV sensitive dyes which can include but are notrestricted to nanoparticles to include but not restricted to Sol gelderived silica is an excellent host material for creating fluorescentnanoparticles by the inclusion of covalently-bound organic dyes,Flourophores that can be organic or inorganic, Fluorite (also calledfluorspar) is a halide mineral composed of calcium fluoride, CaF2.Gemstones, minerals, may have a distinctive fluorescence or mayfluoresce differently under short-wave ultraviolet, long-waveultraviolet, or X-rays, calcite and amber will fluoresce under shortwaveUV. Rubies, emeralds, and the Hope Diamond exhibit red fluorescenceunder short-wave UV light; diamonds also emit light under X rayradiation, Vitamin B2 (fluoresces yellow), quinine (blue), ninhydrin.And fluorescein or an injected material can be metal or a radio-opaquematerial that can be viewed with x-ray and can include but are notrestricted to calcium, iodine, iron and other metals such as titanium,tungsten, barium sulphate, and zirconium oxide and in another embodimentthe marker/localizing device can be a radioactive material that is lowdose and used for diagnostic radiology that can include but is notrestricted to Technecium 99m, Iodine 123 and Iodine131 or Sestamibi99mTc, which can be percutaneously injected directly into the Parathyroidgland. A percutaneous injection would have the advantage overintravenous sestamibi because of the lack of background counts in organsother than the Parathyroid gland 30 such as the local tissue 17, thyroidand fatty tissue and muscles. A radiation sensitive probe such as apencil probe can be used to locate the Parathyroid gland during surgerymore easily and the marker/localizing devices can contain a GPS deviceor contain a material that emits or provides for GPS detection.

The marker can include an LED device.

The marker or localizing device can have a shape that will pierce thetarget tissue but will offer resistance when it is attempted to removethe marker or localizing device. This can include but is not restrictedto a corrugated or angulated or curved or spiral shape, a frictionproducing shape or a shape where target tissue becomes embedded in themarker. The resistance can be controlled such that it is not engaged oractivated until the marker or localizing device lies within the targettissue, parathyroid. In one embodiment the marker can be composed of ametallic alloy such as nitenol that can straighten when thermallystressed with hot or cold and at biological temperatures is corrugatedor angulated or curved or spiral in shape.

The marker or localizing device can be constructed to screw into thetarget tissue.

FIG. 24 a is a guide/wire/placement device 70, a stylet 57 or a tube 52or needle 58 that can leave a marker/localizing device 40 in the targettissue 1, parathyroid. In one embodiment the marker/localizing device 40can contain a transitional zone 45 that contains a transitional statesensitive substance 99 that can be converted from a solid or liquid/gelmaterial that when exposed to a substance 99 or an energy source such asbut not restricted to electromagnetic energy, kinetic or mechanical orthermal energy or forces changes its state and can separate from the amore solid or gel state to a state where the placement device 70 isseparated from the marker/localizing device device 40. In one embodimentthe placement material and the transitional material and themarker/localizing device can all be metallic and if energy 100 such asan electrical current or a thermal force is transmitted though theplacement wire the transitional zone 45 will separate from themarker/localizing device. In another embodiment the placement devicematerial 70 can be composed of a gel that when cold 96 remains solid butwhen heated 98 the transitional zone will melt or dissolve after a givenperiod of time and separate from the marker/localizing device 40.

FIG. 24 b is a placement device that can have groove/threads 66 thatwhen turned or moved in the proper manner will unthread.

FIG. 24 c is an embodiment where the gel can take on crystallinecharacteristics and become more rigid or less rigid when exposed toelectromechanical or kinetic or mechanical energy.

FIG. 24 d is an embodiment of a marker/localizing device 40 can beplaced into the target tissue 1, the parathyroid gland 30 and themarker/localizing device can be attached to a continuous filament/thread38 that can be made of a material that can be organic but not restrictedto silk, cotton or hemp or inorganic such as but not restricted tocarbon filaments or metal.

FIG. 24 e is an embodiment of a marker/localizing device 40 can beplaced into the target tissue 1, the parathyroid gland 30 that can bechanged in shape by and energetic or thermal energy or substance 99 toinclude but not restricted to being straight to pierce the parathyroid30 target tissue 1 and can take on a shape that creates resistance tobeing removed such as a corrugated shape.

FIG. 24 contains a guide or guide wire or placement device, a stylet ora tube or needle that can be left in or can leave a marker/localizingdevice in the target tissue, the parathyroid gland. In one embodimentthe marker/localizing device can contain a transitional zone that whenexposed to a substance or energy. The placement device can havegroove/threads that when turned or moved in the proper manner willunthread. In one embodiment the gel can take on crystallinecharacteristics and become more rigid or less rigid when exposed toelectromechanical or kinetic or mechanical energy. In another embodimenta marker/localizing device can be placed into the target tissue, theparathyroid gland 30 and the marker/localizing device can be attached toa continuous filament or thread that can be made of a material that canbe organic but not restricted to silk, cotton or hemp or inorganicmaterial such as but not restricted to carbon or carbon-carbonfilaments, nylon or rayon, or plastic or metal. A marker or localizingdevice can have a shape that will pierce the target tissue but willoffer resistance when it is attempted to remove the marker or localizingdevice. This can include but is not restricted to a corrugated orangulated or curved or spiral shape, a friction producing shape or ashape where target tissue becomes embedded in the marker. The resistancecan be controlled such that it is not engaged or activated until themarker or localizing device lies within the target tissue, parathyroid.In one embodiment the marker can be composed of a metallic alloy such asnitenol that can straighten when thermally stressed with hot or cold andat biological temperatures is corrugated or angulated or curved orspiral in shape.

FIG. 25 is an embodiment in which a guide 50, guide wire 52, wire/thread53, placement device 70, a stylet 57 or a tube 52 or needle 58 or hooks60 or probes/tines/electrodes 94 can have transitional physicalcharacteristics and can be composed of transitional materials that caninclude but are not restricted to metallic alloys such as but notrestricted to nitenol, transitional gel and can be incorporated into themarker/localizing device 40 but can also be used separately without amarker or localizing device 40.

FIG. 25 a depicts a tube/catheter or conduit 52, needle 58 or guide 50,guide 50, guide wire 52, wire/thread 53, placement device 70, or astylet 57, that can be solid or hollow or can have one or more channels54,56 and when exposed to energy 100 or substance 99 that can includethermal energies such as but not restricted to cold becomes rigid andwhen exposed to heat becomes flexible.

FIG. 25 b depicts a hook 60 or probes/tines/electrodes 94 that can besolid or hollow or can have one or more channels 54,54 and when exposedto energy 100 or substance 99 that can include thermal energies such asbut not restricted to cold becomes rigid and when exposed to heatbecomes flexible.

FIG. 26 is an insulated tube/catheter or conduit 52, needle 58 or guide50, guide 50, guide wire 52, wire/thread 53, placement device 70, or astylet 57, the insulation 43 can include but is not restricted to avacuum FIG. 26 a or a substance solid wall.

FIG. 26 b or a wall with one 54 or more 56 channels. The insulation 43can include a vacuum, or gases or liquids or gels or solids that caninclude but is not restricted to ceramic materials, high aluminumceramics (Alumina Ceramic), beryllium, fiberglass, Zirconium, HighZirconium, adhesives and nansulators, reinforced carbon-carbon fiberconstruction (aka carbon-carbon, abbreviated C/C) is a compositematerial consisting of carbon fibre reinforcement in a matrix ofgraphite, Carbon fibre-reinforced silicon carbide (C/SiC) is adevelopment of pure carbon-carbon (C/SiC utilises silicon carbide withcarbon fibre, and this compound is thought to be more durable than purecarbon-carbon), Fibrous refractory composite insulation (FRCI), LI-900silica tiles, made from essentially very pure quartz sand,High-temperature reusable surface insulation (HRSI), Reaction CuredGlass (RCG), a nansulatecoating, Polytetrafluoroethylene (PTFE) orfluoropolymer of tetrafluoroethylene or a hypophillic or hydrophobicmaterial, ultra-high-molecular-weight polyethylene (UHMWPE) or mineraloil or molybdenum disulfide embedded as additional lubricants in theneedles matrix

FIG. 26 c is a chamber that can be filled with a substance 99 that caninclude a solid or liquid or gel or gas, or chambers that can circulatesubstances to form a heat sink can include are but not restricted to asubstance 99 to include solids, liquids and gels and gasses or a vacuum.

FIG. 27 is an embodiment in which a guide 50, guide wire 52, wire/thread53, placement device 70, a stylet 57 or a tube 52 or needle 58 is placedinto of adjacent to the target tissue a hooks 60 orprobes/tines/electrodes 94 can be used to maintain the position of thetarget tissue 1, parathyroid gland 30. In one embodiment a form ofpositive pressure is created inside the target tissue 1, parathyroidgland 30. One embodiment can include but is not restricted to theplacement of a substance 99 to include one or any combination ofsubstances including but not restricted to solids 76, liquids 78 orgasses 77 or positive or negative pressure or vacuums into the targettissue 1, parathyroid gland 30. This can be used in combination orconjunction with an energy 100 device or source. In another embodimentthe pressure exerted inside of the parathyroid can be negative pressurewhich can use of a substance 99 to include one or any combination ofsolids 76, liquids 78 or gasses 77 or a vacuum 79 exerted upon thetarget tissue 1, parathyroid gland 30. This can be used in combinationor conjunction with an energy 100 device or source or a combination ofpositive and negative pressure. FIG. 27 a represents overall positivepressure and FIG. 27 b is negative pressure.

FIG. 28 is an embodiment of a a tube or conduit 52 that can include butis not restricted to a guide 50, guide wire 52, wire/thread 53,placement device 70, a stylet 57 or needle 58 or hooks 60 that can becomposed of a carbon-carbon or ceramic based structure with a tensilestrength that can be greater than, less than, or equal to equivalent toa similar device with the standard metal qualities for a similar use. Inone embodiment the component/s that pierce can be composed of a but notrestricted to diamond or zirconium and can include but are notrestricted to the leading edge or tip 116. The surfaces inner or outercan be lubricated or made of a material with a low coefficient offriction 117. The transition between the body 118 of the tube or conduit52 proximal to the tip 116 can be a hardened or reinforced 115 material.

FIG. 29 is an embodiment in which a form of delivery packets 103 oragitating 104 substance 99 can be used to increase or decrease theeffect of an energy 100 source to the target tissue 1. parathyroid gland30. The delivery packets 103 or agitating 104 substance 99 can includebut is not restricted to liposomes 101 or microbubbles 102.

FIG. 29 a is an embodiment in which a form of delivery packets 106 oragitating substance 106 can be delivered percutaneously ornon-percutaneously and can be used to deliver a substance 99 such asmedication to ablate the target tissue 30,1. In FIG. 29 a the substancedelivered through the delivery packet does not require a secondsubstance 99 or energy source 100 for activation.

In FIG. 29 b the substance 99 delivered through the agitation substance106 or delivery packet 106 does require a second substance 99 or energy100 source for activation.

In FIG. 29 c the substance 99 delivered through the agitation substance99 or delivery packet 106 does require a second substance 99 or energysource 100 for activation and the energy source can through atranscutaneous device 80 such as but not restricted to ultrasound andHIFU. In one embodiment agitation of the delivery packets 103 can createablation and treatment of the target tissue 1, the parathyroid gland 30.

FIG. 30 is an embodiment of a viewing screen 105 that can be created tomove with and/or track with the viewers eyes 120 or head or body and inone embodiment can include but is not restricted to glasses/goggle/mask105 that can serve as but is not restricted to a display, screen orvisual representation 121, 122. The visual representations can includebut are not restricted to displaying the images 122 or data 123 from animaging device/s 5, 75,81,80 or the treatment device/s 75 or diagnosticdevices 80, 81 or sensor or feedback devices 31 into receivers 124.Imaging sources can include imaging from but not restricted toultrasound, MRI, CT scans, thermal or laser imaging. Data sources caninclude but are not restricted to energy 100 deposition, dimensionaldata such as length and width and depth, temporal data, devices engagedand sensor feedback 31. The data can be transmitted by hard-wiring 119such as but not restricted to cables and fiberoptics and metal wires 119or by non-wire sources 107 such as but not restricted to WI-FI. Inaddition, the display 105 can have the form of glasses/goggle/mask 105that can also protect a portion of the surface or depth of the body orface or of the skin 6, 90. In one embodiment the viewers face orportions of the face 109 can be protected from energy 100 or substances99 that can include but are not restricted to organic or inorganicsubstances 99 or energy 100. In one embodiment the protective device 105and the viewing device 105 can be combined or can be separate and cancontain unique protections such as but not restricted to electromagneticor insulating/thermal protections 43. In another embodiment theprotective device 105 and/or the viewing device 105 can incorporate aseal or barrier 125 that can lie between thedisplay/screen/goggles/glasses 105 and the user's skin or body part thatcan be airtight or watertight or can be breathable and non-airtight orwatertight but provide a protective cushion or interface that preventsenergy 100 or substances from reaching the user to include but notrestricted to the user's skin 90 or eyes 120 or face or other bodyparts. A portion or all of the display/screen/goggles/glasses 105 can beopaque, transparent or translucent. The goggles can be speciallyhardened to resist mechanical debris 99 or energy 100. The display ofthe imaging of the parathyroid 30 target tissue 1 or data 123 caninclude but is not restricted to the image being displayed or projectedon the screen 105 or can be displayed or projected onto the retina 121or can be displayed onto an eternal lens such as but not restricted to acontact lens 126.

DETAILED DESCRIPTION

The general location of parathyroid glands inside a patient's neck skinand trans-cutaneous tissue and nerves. As illustrated, there are usuallyfour, pea-sized parathyroid glands, usually located near the thyroids.In the present invention, devices, systems and methods for applyingenergy (percutaneously or transcutaneously) to a treatment locationwithin, or adjacent, to one or more of these parathyroid gland, in orderto ablate them, or alternatively, to increase glandular functioning (asfacilitated by the application of non-ablative energy to said treatmentlocation) are provided. These methods, systems and devices can furtherbe employed as techniques and methods for treating a variety ofparathyroid-based or related diseases, including but not limited to:hyperparathyroidism, hypercalcemia, and hypoparathyroidism.

For purposes of this disclosure, the parathyroid glands shall in generalbe referenced as 30.

For purposes of this disclosure, “ablation” refers to one or more of thefollowing affects, including but not limited to: thermal tissue damage;tissue destruction; tissue shrinkage; tissue scarring; tissue swelling;tissue remodeling; resection or any process that results in thereduction or altered function, membrane disruption, altered blood flow,cellular death or de-bulking of the parathyroid gland 30.

In addition, “energy” refers to any form of energy, including variousforms of electromagnetic energy, such as: radiofrequency (RF) energy;therapeutic ultrasound energy; microwave, laser, x-ray, or opticalenergy; magnetism, head and cryrotherapy; or any combination thereof.Energy shall also refer to mechanical energy to include but notrestricted to Brownian movement, heat, freezing, crotherapy, cutting,tearing, crushing, spinning, piercing, poking prodding, dividing,removing and segregating or any combination thereof. Nevertheless, forease of illustration, and not limitation, the specific devices andsystems facilitating the treatment methods provided herein, in generalemploy RF or ultrasound energy or laser or piercing or mechanical energyto induce the desired effect in one or more glands. Medication refers toorganic and non-organic agents to include but not restricted to solids76, liquids 78 or gasses 77 that can ablate or alter the function of theparathyroid gland 30 directly or indirectly.

Altered function refers to either increasing or decreasing or modulatingthe function of the parathyroid gland 30.

Visualization of the anatomy can be performed using an imaging device 5that can include but not restricted to ultrasound, x-ray, CT scans, MRI,visual or not visual light sources. The imaging device can include butis not restricted to percutaneous or can be trascutaneous intravascular

A parathyroid gland 30 can be represented as a normal, an enlargedgland, a hyperplasic gland, an adenomatous gland and/or ahyper-functioning gland of the parathyroid 30. There are arterial bloodvessels that create inflow 32 and veins 34 that provide outflow of bloodfrom the parathyroid gland. The innervating nerves 19 of the parathyroid30.

A device can be used to penetrate the skin 90 and the subcutaneoustissue 92 to reach the parathyroid gland. One embodiment can include aneedle 58, which is pointed and has a guiding sheath 50, which allowsrepetitive access to the parathyroid tissue 30.

In one embodiment of treatment is percutaneous where a device puncturesthe skin 90 to access the parathyroid gland through the transdermaltissue 92. Such percutaneous access can utilize but is not restricted tothe use of a needle 58 or guiding sheath/tube/catheter 52. Other formsof percutaneous access can include but are not restricred to a knife, aprobe or a glass or plastic or fiberoptic tube. The puncture device canbe hollow such as but not restricted to a tube. The puncture device canbe solid such as but not restricted to a pointed needle 58, solid knife,member or probe.

A guiding sheath 50 can have a pointed or a blunt end 61. Inside of thesheath 50 can be a tube 52 that can have one 54 or more than one 56channel for the introduction of solids 76, liquids 78 or gasses 77.

The guide shealth or introduction probe device can have rounded marginsand can be but not restricted to a cylinder or ellipse or have pointedmargins and can include but is not restricted to a needle 58 or catheter50. The guide and introduction probe device can have but is notrestricted to non-rounded margins and can be polygonal with multipleflat surfaces and can be but not restricted to triangular, a square, arectangle or pentagon shaped or can have a combination of rounded andsquare surfaces or can be pointed with one of multiple pointed surfacesor can be pointed with one of multiple flat or blunt surfaces.

The guide/introduction probe device 50 can have one 54 or multiplechannels 56. Said channels can be solid or hollow or can be acombination of solid and hollow. The hollow channel can be filled withor transmit a solid 76 or liquid 78 or gas 77. Each of the channels canhave the same or different uses and purposes. One channel can be usedfor visualization of the parathyroid and the second channel can beutilized for treatment and/or treatment of the parathyroid. In anotherembodiment but not restricted to this embodiment, there can be twochannels with one channel used for visualization of the parathyroid andthe second channel can be utilized for biopsy of the parathyroid.Channels can have multiple combinations of uses.

In another embodiment but not restricted to this embodiment, there canbe two channels one channel can be used for treatment of the parathyroidand the second channel can be utilized for biopsy of the parathyroid. Inthis example shown the visualization is external and one channel 54 isused for biopsy and the other channel is used for introduction ofmedication 99.

In another embodiment but not restricted to this embodiment, there canbe more than two channels in which one channel can be used for treatmentof the parathyroid and the second channel can be utilized for biopsy ofthe parathyroid and a third channel can be used for visualization (notshown). This visualization can be with a fiberoptic tube/camera, anultrasound probe but is not restricted to ultrasound and/or fiberopticvisualization.

A guiding sheath 50 penetrating the parathyroid tissue 30 can have anaccessory tube 52, which provides for the passage of solids 76, liquids78 or gasses 77 material(s) 99. The tube 52 is in proximity to theparathyroid tissue 30 the artery 32 the nerve 19 and the vein 34. Thisprovides for direct insinuation of the solids 76, liquids 78 or gasses77 material into the parathyroid tissue 30 without leakage outside ofthe parathyroid gland 30. The tubes, which can include but are notrestricted to the guiding sheath 50 and accessory tube 52 can, includemethods for securing the tube to the tissue including permanent orretractable burs/projections and screw like threads.

In association with the sheath 50 there can be an additional tube 51,which provides for the passage of solid 76 or liquid 78 or gas 77material(s) and can serve multiple functions to include but notrestricted to insulation. The tube 52 is in proximity to the parathyroidtissue 30 the artery 32 and the vein or nerve (not shown). The soliddevice/probe/member can have multiple uses that include but are notrestricted to treatment, localization and visualization of theparathyroid 30. Traversing the tube/conduit 52 is a soliddevice/probe/member that can be used to partially or fully ablate theparathyroid tissue 30 or the parathyroid arteries 32 or veins or nerve(not shown).

Methods for external device and internal probe/member/device 75visualization can include but are not restricted to fiber-optic,ultrasound, thermographic, motion detection chromographic, blood flowdetection, x-ray, ultraviolet, infrared as well as other detectors usingthe electromagnetic spectrum or kinetic/mechanical imaging or measuringdevices. The visualization of the parathyroid 30 can occur on the skin90 or within the body to include but not restricted to the subcutaneoustissue 92, blood vessels (34,32), hollow organs, orifices and other bodyparts (not shown) that can serve as windows of visualization.

The abnormal parathyroid 30 glands are usually an orange color and thisunique quality can be used to visualize the abnormal parathyroid glandusing a color/chromographic detection technology to include but notrestricted to transcutaneous, precutaneous, within the body or acombination of the above forms of imaging. The color identificationsystem can involve using a light or energy source that is external orinternal and that can be detected externally or internally or anycombination of the above.

One method depicted in FIG. 6, is a probe/member/device 75 that can beused as a method for treatment of the parathyroid tissue 30 that canutilize a probe/member/device 75 that can include but not restricted toelectromagnetic energy; radiofrequency energy; photoelectric energy;laser energy to include but not be restricted to hot lasers and coldlasers and intermediate lasers; ultraviolet energy, infrared energy,radioactive energy or x-ray energy in its various configurations.

In another method a probe/member/device 75 that can be used as a methodfor treatment of the parathyroid tissue 30 that can utilize aprobe/member/device 75 that can include but not restricted to the formsof mechanical/kinetic energy including but not restricted to ultrasoundenergy including but not restricted to high frequency ultrasound (HIFU);heat, including but not restricted to laser directed heating; a directheat source including but not restricted to metal or ceramic materialsor a combination of different metals and ceramic materials; cold,including but not restricted to laser directed cooling or freezingdevice; a direct cooling or freezing source including but not restrictedto metal or ceramic materials or a combination of different metals andceramic materials; dry ice, hot or cold solids 76, liquids 78 or gasses77.

With a sheath 50 penetrating the parathyroid tissue 30, there can be anadditional tube 52, which provides for the passage of solids 76, liquids78 or gasses material(s) and can serve multiple functions to include butnot restricted to insulation. The tube 52 is in proximity to theparathyroid tissue 30 the artery 32 and the vein 34. Traversing thetube/conduit 70 can be a hollow device 75 that can be used to partiallyor fully ablate the parathyroid 30 or the parathyroid arteries 32 orveins (not shown) that can deliver one or any combination of solids 76,liquids 78 or gasses 77.

One method can include parathyroid treatment that can utilize but notrestricted to the many forms of chemical agents to include solids 76,liquids 78 or gasses 77 that can include but are not restricted tosclerosing agents that can include but are not restricted to ETOH,Bleomycin, Tetracycline and Doxycycline; chemical reactions that induceheat or cold; direct injection or heated materials to include but notrestricted to heated metal; direct injection of cooling or freezingagents to include but not restricted to dry ice solid carbon dioxide andliquid nitrogen; the expansion of tissue interrupting blood flow byincreasing the tissues internal pressure such that the tissue pressureapproached or exceeds arterial systolic and diastolic pressure orwhereby the venous channels become obliterated thus trapping blood andpreventing egress of blood outside of the parathyroid tissue thusdecreasing both venous outflow and arterial inflow with agents toinclude but not restricted to water or gels (not shown) or solids 76,liquids 78 or gasses 77 to include but not restricted to oxygen, carbondioxide and nitrogen. Agents that can poison the parathyroid tissue 30can include but are not restricted to solids 76, liquids 78 or gasses 77including but not restricted to ammonia, arsenic, acids and bases. Theagents and techniques described in FIG. 7 can be directed to othertissue in the vicinity of the target tissue to include but notrestricted to nerves 19 or subcutaneous tissue 92 to obtain similareffects.

Another method is the treatment of the parathyroid tissue, byintroducing the treatment agent to the parathyroid gland 30 and localtissue 92, or at or in the parathyroid tissue 30 or the parathyroidfeeding vessels 32,34 and nerves 19, including but not restricted to thearteries and veins can utilize but not restricted to bleeding agents anddevices, such that the bleed occurs inside of the parathyroid andincreases the pressure inside of the parathyroid and perturbs blood flowinto or out of the parathyroid and ultimately destroys either a part orall of the parathyroid gland.

In another method, treatment of the parathyroid tissue can includeintroducing the treatment agent to the local tissue, or at or in theparathyroid tissue or the parathyroid feeding vessels 32,34, includingbut not restricted to the arteries 32 and veins 34 can utilize but notrestricted to clotting agents and devices, such that the clot occursinside of the parathyroid and increases the pressure inside of theparathyroid and perturbs blood flow into or out of the parathyroid andultimately destroys either a part or all of the parathyroid gland 30.

In another method the treatment of the parathyroid tissue 30, byintroducing the treatment agent to the local tissue 92, or at or in theparathyroid tissue 30 or the parathyroid feeding vessels (32, 34) ornerves 19, can utilize but not restricted to the many forms of poisoningof the parathyroid tissue to include but not restricted to chemicalagents both inorganic and organic agents to include but not restrictedto biological agents such as but not restricted to parathyroid directedantibodies or antibodies to the agents specific to the parathyroid;serum or blood that has incompatibility with the patient such as but notrestricted to blood type A, B, O, AB or RH factors positive or negative;biochemical agents such as but not restricted to angio-toxic agents thatdamage blood vessels such as but not restricted to thalidomide; andinert agents to include but not restricted to chemical poisons such asbut not restricted to arsenic, and sulfur. Expansile agents such as butnot restricted to hydro-gels; bleeding agents such as platelet andclotting factor inhibitors; clotting agents such as but not restrictedto kaolin and zeolite.

Another method is the treatment of the parathyroid tissue 30, byintroducing the treatment agent to the local tissue 92, or at or in theparathyroid tissue 30 or the parathyroid feeding vessels (32, 34) ornerves 19, can utilize but not restricted to the many forms of macro,micro, and nano technology whereby the parathyroid tissue is disturbedin a manner that makes it non-functioning by using masceration oftissue, grinding of tissue, destruction of tissue through friction orcutting or piercing through mechanic methods or through the depositionof energy that can include but is not restricted to electromagnetic andkinetic/mechanical energy.

The treatment of the parathyroid tissue 30, by introducing the treatmentagent to the local tissue 92, or at or in the parathyroid tissue 30 orthe parathyroid feeding vessels (32, 34) or nerves 19, can utilize butnot restricted to inject of antibodies in the blood stream that targetthe parathyroid 30. Organic and inorganic agents can be used thatmodulate or poison or make the parathyroid gland inactive or destroys acomponent or all of the parathyroid gland 30.

In another method the abnormal parathyroid gland 30 can be exposed toone of more treatment agent that can be activated when exposed toanother treatment agent. In one example a energy activated poison can beactivated when the parathyroid tissue 30 is exposed to energy that caninclude energies such as but not restricted to electromagnetic energyand kinetic/mechanical energy and can include but are not restricted tothe photo sensitive or radioactive, ultrasonic or heat or cold sensitivepoisons that are exposed to the proper electromagnetic spectralwavelength, ultrasonic wavelength, heat or cold from an external device(5, 80) or an internal device 75. In another example one agent can beprotective and can modulate the treatment agent while the other agentcan be the active treatment that. In another example one agent can be anadjuvant facilitating or increasing the effectiveness of the treatingagent. In another example one agent can slow or stop the reaction of thetreating agent.

In one embodiment the treatment of the parathyroid 30 can be performedusing a coagulation agent's device. The coagulation agent's device canbe on the skin 6 the coagulation agents device can be external andseparated from the skin with or without a membrane or substance thatbridges the coagulation agents and the skin 6. The coagulation agent'sdevice can be internal relative 92 to the body and below the surface ofthe skin 90. Coagulation agent's device can lie on or near the surfaceof the parathyroid in order to treat the parathyroid 30. The coagulationagent's device can puncture the parathyroid 30 to treat the parathyroid30. The coagulation agent's device device can lie on or near the surfaceof a parathyroid artery 32 or vein 34 in order to ablate the parathyroidblood flow. The coagulation agent's device 75 can puncture a parathyroidartery 32 or vein 34 in order to ablate the parathyroid blood flow. Thecoagulation agent's device can fully or partially ablate theparathyroid. The coagulation agent's device can fully or partiallyablate the artery 32 or vein 34 to the parathyroid.

Antibody agent (antiparathyroid antibody either produced from patientsparathyroid or generic). In one embodiment the parathyroid treatment canbe performed using an antibody agent. The antibody agent delivery device75 can puncture the parathyroid to ablate the parathyroid. The antibodyagent delivery device 75 can lie on or near the surface of a parathyroidartery 32 or vein 34 in order to treat the parathyroid blood flow. Theantibody agent can puncture a parathyroid artery 32 or vein 34 in orderto ablate the parathyroid blood flow. The antibody agent can fully orpartially ablate the parathyroid the antibody agent can fully orpartially ablate the artery or veins to the parathyroid. The antibodyagent can be delivered systemically to include but not restricted tobeing delivered in an artery 32 or vein 34.

In one embodiment the treatment of the parathyroid 30 can be performedusing a medication delivery system device (75, 77, 80). Medication caninclude but is not restricted to sclerosing agents, sensipar,antibodies, modulating agents to include but not restricted to agentsthat stimulate the parathyroid genome, and Calcium and Vitamin D thatsuppress the protective agents such as but not restricted toanti-radiation and anti-oxidation agent, bases and acids. The medicationdelivery system device (75, 80) can be on the skin. The medicationdelivery system device (75,80) can be external and separated from theskin with or without a membrane or substance that bridges the medicationdelivery system device (75, 80) and the skin 90. Medication deliverysystem device (75, 77, 80) can be internal relative to the body 92 andbelow the surface of the skin 90. Medication delivery system device (75,80) can lie on or near the surface of the parathyroid in order to ablatethe parathyroid. The medication delivery system device (75, 80) canpuncture the parathyroid to ablate the parathyroid 30. The medicationdelivery system device (75, 80) can lie on or near the surface of aparathyroid arteries 32 or veins 34 in order to ablate the parathyroidblood flow. The medication delivery system device (75, 80) can puncturea parathyroid arteries 32 or veins 34 in order to ablate the parathyroidblood flow. The medication delivery system device (75, 80) can fully orpartially ablate the parathyroid the medication delivery system device(75, 80) can fully or partially ablate the artery or veins to theparathyroid. The medication delivery system device (75, 80) candeactivate the parathyroid either by destroying the gland rapidly orover a more prolonged period of time. The medication delivery system candecrease parathyroid functions without destroying the gland. Themedication can be titrated to insure proper parathyroid levels withinthe body. The medication delivery device can treat the local tissue 92,the nerves 19, the arteries 32 or veins 34. The medication can beprotective to the parathyroid 30 or it can modulate function or it canbe destructive.

One embodiment can include but is not restricted to an energy deliverydevice 75, 80 for ablating one or more parathyroid glands 30. The energydelivery device 75, 80 delivers energy 100 to ablate parathyroid tissue30 preferably while surrounding tissues 17, anatomical structures(including, e.g., nerves 19, vessels 32, thyroids 20) are preserved. Inone possible embodiment, energy delivery device 75, 80 comprises anelongated member having an energy 100 delivery member disposed at adistal end thereof. In one possible implementation, one or more lumensextend through a portion, or the entire length, of elongated member andare configured as pathways for the used for the delivery of delivery ofsolids 76, liquids 78 or gasses 77. The energy delivery device isdeliverable though a transcutaneous device 80 allowing for the minimallyinvasive, or non-invasive, ablation of the parathyroid glands 30. Theenergy delivery member can be coupled to energy generator 23. In thisembodiment, the energy delivery device 80 and the energy delivery devicecan be coupled together. In this embodiment, energy delivery device 26comprises other device components; including controller 7 coupled tofeedback sensors disposed on the distal end of energy delivery device.

In one embodiment the device uses electromagnetic energy 100 for eitherdiagnostic or therapeutic purposes. The energy is directed at a bodytissue to include but not restricted to the parathyroid 30 and can bedirected toward its vascular supply including the arteries 32, veins(not shown) and the nerves. The electromagnetic energy can pass throughthe skin 6 and subcutaneous tissue 92. In one embodiment one of thechannels can be used for localization/visualization of tissue 27.

In one embodiment of an energy delivery device delivers energy to ablatetissue of the target tissue, preferably while surrounding tissues,anatomical structures (including, e.g., nerves 19, vessels 32, thyroids20, 22) adjacent glands 30 are preserved.

In one possible embodiment, the energy delivery device 80 comprises anelongated member having an energy delivery member that can be exposed atits distal end. In one possible implementation the active component ofthe energy delivery probe can use cables or connectors, catheters,guidewires, pullwires, insulated wires, optical fibers, and/or imagingdevices, feedback systems, to expose the energy delivery componentrelative to the insulated component. In a preferred embodiment, theenergy delivery device is deliverable though an imaging device through atube or conduit 52 or guide 50 and can include but is not restricted toan endoscope, catheter, and introducer device, allowing for the tightlytargeted minimally invasive, or non-invasive, ablation of target tissue1. The energy delivery probe can be coupled to an energy generator 23.

In one embodiment, an energy delivery member, or at least a portion orthat device, can be directly inserted into gland 30 to facilitatecontact between the delivery device probe and the target tissue 1, theparathyroid gland.

In another embodiment, energy delivery member may be a RF probecomprising a monopolar or bipolar or multipolar electrode(s) coupled toa distal end of a probe. The distal end of the RF probe can beconfigured to be directly inserted into parathyroid gland 30facilitating direct contact between the one or more RF electrodes andglandular tissue 30.

As will be readily appreciated by one skilled in the art, severaltechniques can be implemented to facilitate identification and locationof glands 30 to be treated or ablated. In one possible implementation,and as a described in U.S. Pat. No. 6,263,232, glands 30 may beidentified and located through radio-labeling and employing one or moreradioactivity sensors coupled to energy delivery device to detect them.In the present, preferred embodiment, energy delivery device comprisesone or more radioactivity sensors coupled to the distal end; thusallowing for detection of a radiolabel administered to the patient priorto, or during, the treatment procedure and accumulated in glands 30facilitating identification, location and treatment thereof.

In yet another possible implementation, standard visualizationtechniques, including: ultrasound; MRI; and/or CT imaging (just to namea few), can be separately or simultaneously employed to aid in theidentification and location of parathyroid glands 30 to be treated orablated. In this embodiment, the energy delivery device is image-guidedto the appropriate location where energy delivery can be initiated. Auser viewable monitor is coupled to energy delivery device to facilitateimage-guidance of energy delivery device.

In yet another embodiment, image and radio-guidance techniques can beimplemented together to ensure identification, location and position ofenergy delivery device.

In yet another embodiment, energy delivery device comprises other devicecomponents, including controller coupled to feedback sensors disposed onthe distal end of energy delivery device. Controller is configured toreceive and process one or more signals from feedback sensors disposedon the distal end of energy delivery device. Feedback sensors providesignals, which can be processed to regulate one or more of the followingprocesses, including but not limited to: energy delivery; extent oftissue ablation; termination of energy delivery, etc. Said feedbacksensors can be configured to detect, and/or, monitor, for example,tissue temperatures, tissue impendence, electrical signals or nerveimpulses. Yet another feedback mechanism, which can be employed toregulate one or more of the processes described above, includes periodicvocalization from the patient, before, during or after the treatment. Aswill be readily appreciated by those skilled in the art, periodvocalization can be used to ensure no or minimal vocal cord paralysis asa result of treatment.

In a further embodiment, a patient's parathyroid hormone serum levelsand/or calcium levels can also be monitored (before, during and/or aftertreatment) to assist in the regulation of the energy delivery process,as well as, determine the appropriate extent of tissue ablation orstimulation. For instance, parathyroid gland 30 can be ablated until adetectable decrease in a patient's parathyroid hormone or calcium levelsare reached. Alternatively, glands 30 can be stimulated until anincrease in a patient's parathyroid hormone levels are detected.

One general method of using energy delivery device includes advancing aguiding catheter, endoscope, introducer or other like device through, apreferably small puncture or incision on the patient's skin until thedistal tip of said catheter/endoscope/introducer is seated adjacent tothe parathyroid gland 30 to be treated. Image and/or radio-guidance, asprovided above, can be employed to position saidcatheter/endoscope/introducer adjacent gland 30 to be treated.

Energy delivery device is then introduced though thecatheter/endoscope/introducer and the distally located energy deliverymember positioned to affect ablation or treatment of the parathyroidgland 30. When energy delivery device or energy delivery member isadequately positioned, energy, for example high frequency electricalenergy, to include but not restricted to MW, IRE, laser and in the RFrange, is directed through energy delivery member to the one or more RFelectrodes or probes to the parathyroid gland 30 to ablate the targettissue or form an ablative lesion of a desired size and shape. Typicallyhigh frequency electrical energy levels of about 5 to about 100 Watts,preferably about 30 to about 70 Watts, are suitable to ablate tissue.Typical lesions formed are about 3 mm to about 20 mm in diameter andabout 3 mm to about 20 mm in length. As will be readily apparent to oneskilled in the art, these operational parameters can be modified and thesystem configured in order to facilitate the suitable partial or wholeablation of one or more parathyroid glands. Other generally suitabledevices and system that can also be employed are described in U.S. Pat.No. 6,016,452, U.S. application Ser. No. 10/621,839, U.S. Pat. No.6,494,886 the contents of which are hereby incorporated by reference. Asdiscussed, various feedback sensors and monitoring techniques may beemployed to regulate or monitor energy delivery.

Another implementation of energy delivery device for the partial orcomplete ablation of one or more parathyroid glands 30. In thisembodiment, energy delivery device is configured as a percutaneouslyinserted probe 24 as described in co-pending U.S. patent applicationSer. No. 10/671,417 filed Sep. 24, 2003, the contents of which arehereby incorporated by reference in their entirety. Similar to energydelivery device, probe is preferably configured to be introduciblethough an endoscope, catheter, introducer or other like device tofacilitate the non-invasive, or minimally invasive, delivery of saidprobe. As further described in co-pending U.S. patent application Ser.No. 10/671,417, insertable probe 24 can be used to ultrasonically ablatetissue using therapeutic ultrasound energy or high intensity focusedultrasound energy (“HIFU” energy). As described above, the probe, isimage and/or radio-guided to glands 30 and one or more feedbackmechanisms is employed for purposes of: controlling energy delivery,ensuring controlled ablation of tissue, determining an endpoint of thetreatment, etc. as provided above. The probe can house at a minimumtherapeutic acoustic transducers (or emitters), which, when actuated byan energy generator 23, transmit therapeutic ultrasound or HIFU energysufficient to ablate glandular tissue.

Another embodiment of energy delivery device allows for thetranscutaneous ablation of the parathyroid gland 30. As will be readilyappreciated by one skilled in the art, one of the design advantages ofutilizing therapeutic ultrasound energy or high intensity focusultrasound (“HIFU”) is that the ultrasound energy may be deposited to aremote location without damaging intervening tissues or structures. Thisis accomplished by focusing the therapeutic ultrasound energy or HIFU toa focal location as generally HIFU employs high-intensity convergent, or“focused,” ultrasound energy, or beams (generated by a high powerultrasound transducers or therapeutic tranducers), to affect tissueheating and ablation. In this implementation, HIFU is intended to allowablation of parathyroid tissue without damaging intervening andsurrounding tissue, eliminating the need for incisions or insertion ofdevices, etc. and any resulting complications. Moreover, the size orvolume of tissue to be ablated may be optimized and/or changed dependingon the specific operational parameters (frequency, phasing/timing,voltages) or drive strategies employed to activate the high power ortherapeutic transducer. General descriptions of various therapeutic orHIFU devices and systems that generally may be adopted to ultrasonicallyablate a parathyroid gland are provided in U.S. Pat. Nos. 5,354,258;5,150,711; 6,685,639; 6,508,774; 6,217,530; 5,995,875; 6,016,452;6,666,835; and 6,656,136 the entire contents of which are herebyincorporated by reference.

An energy delivery device is adapted to transcutaneously focustherapeutic ultrasound energy to a focal location within a parathyroidgland to ablate tissue. In this embodiment, energy delivery devicegenerally comprises an ultrasound applicator housing at least oneultrasound transducer or transducer assembly configured to emittherapeutic ultrasound energy or HIFU when actuated by an energygenerator. The ablative therapeutic ultrasound energy or HIFU energy isdelivered through a patient's skin to the treatment location on thegland. The treatment, or duration in which energy is applied, can changeor be optimized according to the amount, extent or volume of tissue 30to be ablated. Generally, the ultrasound applicator is placed againstthe patient's neck and configured to be hand-held for easymanipulability.

As with the other devices, the transcutaneous energy delivery device canincorporate various other devices and system components which may aid inthe identification and localization of glands and/or for the controlleddelivery of ablative energy. In one embodiment, energy delivery devicecan be configured to allow for image-guidance of the therapeuticultrasound energy to the gland 30. In yet another embodiment,radio-guidance of the therapeutic ultrasound energy may be implemented.Various strategies that can be further implemented for directing theappropriate amount or dose of therapeutic ultrasound energy to treat orablate one or more glands 30 are provided in U.S. Pat. Nos. 4,922,917;6,425,867; and 6,726,627 the entire contents of which are herebyincorporated by reference.

In accordance with yet another aspect of the invention, devices andsystems described herein can be adapted to allow for the delivery ofnon-ablative energies thus facilitating the stimulation of glandularfunction and providing a treatment for hyperparathyroidism.

While the present invention has been described in detail with referenceto preferred embodiments thereof, it will be apparent to one skilled inthe art that various changes can be made, and equivalents employed,without departing from the scope of the invention. For example, thedescribed methods can be implemented for the treatment of other glands,such as the adrenal gland.

In another embodiment a device that uses electromagnetic or mechanicalenergy for either diagnostic or therapeutic purposes. The energy isdirected at a body tissue to include but not restricted to theparathyroid 30 and can be directed toward its vascular supply which caninclude the arteries 32, the veins (not shown) or the nerves 19. Theelectromagnetic or mechanical energy 82 can pass through the skin 90 andsubcutaneous tissue 92. A delivery tube/needle 84 can penetrate the skin90 and subcutaneous tissue 92 and the target tissue to include but notrestricted to the parathyroid 30 and its vascular supply and nerves (notshown, in this embodiment the arteries 32. A solid 76, liquid 78 or agas 77 substance or a combination of these substances can be deliveredto the parathyroid. In one embodiment the guidance of the needle andsubstance placement is visualized or measured by the device 80. Inanother embodiment the device 80 can activate or deactivate the solid76, liquid 78 or a gas 77 substance. More than one device or deliverytube/needle can be used or multiple combinations of these devices ordelivery tube/needles 52,58 or electromagnetic or mechanical energies 80can be used (not shown). The local subcutaneous tissue 92 and nerves 19can be modified using by the delivery of energy 80 or substance 99,non-energetic methods to protect the local tissue which in thisembodiment is the subcutaneous tissue.

In one embodiment the parathyroid gland may be over functioning, normalfunctioning or under functioning. A method for modulation which caninclude stimulation or reduction or cessation of the parathyroid gland30 is described which can be temporary or permanent. A form ofparathyroid pacemaker can be used to modulate the parathyroid function.This can be used for the treatment of an overactive parathyroid causingosteoporosis or an under-active parathyroid or a normal parathyroid thatneeds to be stimulated to induce bone growth and development. Eventhough the parathyroid gland when over-active will reduce bone mineral,the parathyroid gland 30 does control osteoclast and osteoblast activityand when timed and dosed in the proper many can induce an equilibriumthat may increase bone growth. This can be done using parathyroidhormone release alone or in combination with organic substances such asbut not restricted to parathyroid hormone, calcitonin, growth hormone,peptides, hydroxyapetitie and can be use with inorganic substances suchas but not restricted to Calcium, Phosphorus and other bone minerals.The substances and the stimulation can be used together in multiplecombinations and with multiple temporal relations or stimulation anddelivery.

In one embodiment energy which can include but is not restricted toelectromagnetic and mechanical energy and can be used to stimulate theparathyroid gland 30. This can be performed by stimulating the nerves19, the arteries 32, the veins 34 and the parathyroid tissue 30 or anycombination of these structures.

In one embodiment, non energy substances, which can include but is notrestricted to parathyroid hormone, a component of the parathyroidhormone, a new derivative peptide with the elements of the parathyroidhormone and contains the active amino acid sequence, andneurotransmitters can be used to stimulate the parathyroid gland 30.This can be performed by stimulating the nerves 19, the arteries 32, theveins 34 and the parathyroid tissue 30 or any combination of thesestructures.

The modulation, activating and de-activating methods which include butare not restricted to medication/substance or energy source can beinstilled into the parathyroid or around the parathyroid or from theskin in a transcutaneous manner.

In one embodiment the energy source and the energy can be placed on theskin or near the skin but not through the skin near the parathyroid.

In this embodiment a substance/medication that has been delivered to theparathyroid must be activated or de-activated by the energy source. Thedelivery method of the substance can be but is not restricted to adelivery method that includes through a blood vessel (intravenous orintra-arterial); or through a needle to include through the skin orsubcutaneous tissue; or via a transcutanous method. Thesubstance/medication 99 can utilize and organic substance such as butnot restricted to a targeted antibody or cell receptor; or a non organicsubstance such as but not restricted to an element or molecule such asbut mot restricted to Calcium; a medication to include but notrestricted to sestamibi or Sensipar (cinacalcet).

In one embodiment there can be more than one substance that must act inconcert with the energy to prevent local tissue damage. These substancescan be dependent upon each other for activation prior to, after orduring energy activation.

In another embodiment the energy source and the energy can be placed ordelivered to or near the parathyroid using a percutaneous;transcutaneous technique such that the energy source is within; or indirect contact with the parathyroid; or intimate but not into or indirect contact with the parathyroid gland.

In another embodiment, the energy source and the energy can be placedthrough a blood vessel and delivered to or near the parathyroid using atechnique such that the energy source is within; or in direct contactwith the parathyroid; or intimate but not into or in direct contact withthe parathyroid gland.

In one embodiment there can be one or multiple energy sources.

In another embodiment there can be one or multiplemedication/substances.

By combining one or a combination of substances and one or a combinationof energies or energy sources or one or more delivery systems theparathyroid can be modulated, activated, de-activated or even ablatedover time from disuse and the ablation can be partial or complete or theparathyroid can be induce to grow and increase its function especiallyin patients with under-active parathyroid glands which can occur but notrestricted to aggressive surgical resection, transplantation of theparathyroid gland 30, or prior radiation that damages the parathyroidgland 30.

One embodiment can include a method to activate or de-activate thetreatment effect on the parathyroid 30 and surrounding tissue 17 or canhave any combination or modulation or variation of activation anddeactivation on the parathyroid 30 or local tissue 17 by altering theeffects of the medication/substance or energy source on the parathyroid30 or local tissue 17. The treatment agent can be energy and can includebut is not be restricted to electromagnetic or mechanical/kineticenergy. The treatment agent can be a substance that can be but is notrestricted to a medication that can be but is not restricted to organicor non-organic and can be instilled into the parathyroid gland 30 oraround the parathyroid local tissue 17 by using a method that can be butis not restricted to a percutaneous technique to include but notrestricted to a needle; an osmotic method to include but not restrictedto DMSO or ultrasonic activated lipophilic packets or UV light on acement-like or glue like material to include UV light and glass ionomercement (GIC). In one embodiment, the energy source and the energy andthe treatment agent can be placed on the skin 6 or near the skin but notthrough the skin 6, 90.

In another embodiment, the energy source and the energy and thetreatment agent can be placed through the skin/percutaneous. In anotherembodiment, the energy source and the energy and the treatment agent canbe placed in any combination of through the skin/percutaneous 92 or notthrough the skin but rather on the skin (6, 90). In one embodiment atreating substance/medication that has been delivered to the parathyroidmust be de-activated by the energy source. The delivery method of thesubstance can be but is not restricted to a delivery method thatincludes through a blood vessel (intravenous or intra-arterial); orthrough a needle to include through the skin or subcutaneous tissue; orvia a transcutanous method. The substance/medication can utilize andorganic substance such as but not restricted to a targeted antibody orcell receptor; or a non organic substance such as but not restricted toan element or molecule such as but mot restricted to Calcium; amedication to include but not restricted to sestamibi or Sensipar(cinacalcet).

In one embodiment there can be more than one substance that must act inconcert with the energy to activate or deactivate or cause or preventlocal tissue damage. These substances can be dependent upon each otherfor activation or deactivation. Prior to or after or during energyapplication.

In another embodiment, The energy source and the energy can be placed ordelivered to or near the parathyroid using a percutaneous;transcutaneous technique such that the energy source is within theparathyroid tissue 30; or in direct contact with the parathyroid gland30; or intimate but not into or in direct contact with the parathyroidgland 30.

In another embodiment The energy source and the energy can be placedthrough a blood vessel and delivered to or near the parathyroid using atechnique such that the energy source is within; or in direct contactwith the parathyroid; or intimate but not into or in direct contact withthe parathyroid gland.

In one embodiment there can be one or multiple energy sources.

In another embodiment there can be one or multiplemedication/substances.

By combining one or a combination of substances and one or a combinationof energies or energy sources, the parathyroid 30 can be ablatedpartially or completely, the parthyroid 30 can be activated orde-activated or the surrounding tissue 92 and vital structures toinclude but not restricted to the vital nerves 19 can be protected orpartially or completely ablated or injured.

One embodiment uses a protective material in the zone around theparathyroid 30 that can be activated with or without anothersubstance/medication or energy and facilitates the protection of thelocal tissue 17 which can include but is not restricted to a weak baseif an acid is used to ablate the parathyroid 30.

One embodiment uses a destructive material in the parathyroid 30 thatcan be activated with or without another substance/medication or energyand facilitated the destruction of the parathyroid which can include butis not restricted to UV light and glass ionomer cement to ablate theparathyroid 30.

In one embodiment the treatment can be performed by Radio FrequencyAblation Device (RFAD). Utilizing parathyroid imaging including aninternal device 75 or an external device 80 that can include but is notrestricted to ultrasound device directed to identify thehyper-functioning parathyroid gland 30.

Examples of methods of treatment can include but are not restricted to:

In one embodiment the treatment device can include but is not restrictedto an RF treatment device in which the energy is directed into the bodyutilizing imaging that can include but is not restricted to ultrasoundand the RF energy is focused to treat the organ to include but notrestricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The Radiofrequency device can be internal relative to thebody and below the surface of the skin (6, 90) and within the body partsthat can include but is not restricted to subcutaneous tissue, holloworgans. blood vessels, orifices and other body parts or a combination ofthese body parts that provide access to the parathyroid 30. TheRadiofrequency device can lie on or near the surface of the parathyroidin order to treat the parathyroid 30. The Radiofrequency device 75 canpuncture the parathyroid 30 to treat the parathyroid or it can enter abody part that is a hollow organ or orifice or a combination of thesebody parts. The Radiofrequency device can lie on or near the surface ofa parathyroid artery or vein in order to treat the parathyroid 30. TheRadiofrequency device can puncture a parathyroid artery or vein in orderto ablate the parathyroid blood-flow. The Radiofrequency device canfully or partially ablate the parathyroid 30 The Radiofrequency devicecan fully or partially ablate the artery or veins or nerves to theparathyroid or damage the local tissue in and near the parathyroid 30.

In another embodiment the Radiofrequency device 75 can be on the skin.The Radiofrequency device 75 can be external 80 and separated from theskin with or without a membrane or substance that bridges theRadiofrequency and the skin.

In one embodiment the treatment can be performed by High FrequencyUltrasound (HIFU) utilizing parathyroid imaging including an internaldevice 75 or an external device 80 that can include but is notrestricted to ultrasound device directed to identify thehyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an HIFU treatment device in which the energy is directed into thebody utilizing imaging that can include but is not restricted toultrasound and the HIFU energy is focused to treat the organ to includebut not restricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The HIFU device can be internal relative to the body andbelow the surface of the skin (6, 90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs.blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. The HIFU devicecan lie on or near the surface of the parathyroid in order to treat theparathyroid 30. The HIFU device 75 can puncture the parathyroid 30 totreat the parathyroid or it can enter a body part that is a hollow organor orifice or a combination of these body parts. The HIFU device can lieon or near the surface of a parathyroid artery or vein in order to treatthe parathyroid 30. The HIFU device can puncture a parathyroid artery orvein in order to ablate the parathyroid blood-flow. The HIFU device canfully or partially ablate the parathyroid 30 The HIFU device can fullyor partially ablate the artery or veins or nerves to the parathyroid ordamage the local tissue in and near the parathyroid 30.

In another embodiment the HIFU device can be on the skin. The HIFUdevice can be external and separated from the skin with or without amembrane or substance that bridges the HIFU and the skin.

An Electromagnetic device (EMD) can include but is not restricted toRadiofrequency ablation (RF) and microwave (MW) and laser (L),Cryotherapy (CryT), Hight Intensity Focused Ultrasound (HIFU),Radioactive Therapy (Brachytherapy: BrT), Irreversible Electroporation(IRE), Electrical Current Therapies, Electrocautery, Magnetic Resonance(MR), Ultrasound, (US), Thermal energies both heat 98 and cold 96. AndEMD can be used with mechanical or kinetic energies and with adjuvantcombinations that can include but are not restricted to medicationdelivery, Medication packets, blood flow reduction, Chemical andMedication Ablation, Activation and Deactivation and Modulation Therapy,Adhesives and Glues and Molecular Crystal and Lattice therapies, TargetTissue Delivery Device Therapies, Peptide and Biological ConversionTherapies, MR and RF and Magnetic External Heating Therapies,Hyperthermia with Adjuvant Therapy, Hypothermia with Adjuvant Therapy,Local protective therapy in the Vicinity of the Target Organ Therapy,Suction and Expansion Therapy, Positive Pressure and Expansion Therapy,Mechanical Ablation Therapy and Combinations of Therapies.

In one embodiment the ablation can be performed using an ElectromagneticEnergy Delivery Device (EMED). The EMED can deliver continuous energyThe EMED can deliver non-continuous energy to included but notrestricted to pulsed energy. The EMED can deliver continuous energy thatcan be modulated to increase of decrease the energy delivered. The EMEDcan deliver non-continuous energy that can be modulated to increase ofdecrease the energy delivered.

In one embodiment the treatment can be performed by (EMED) utilizingparathyroid imaging including an internal device 75 or an externaldevice 80 that can include but is not restricted to ultrasound devicedirected to identify the hyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an EMED treatment device in which the energy is directed into thebody utilizing imaging that can include but is not restricted toultrasound and the EMED energy is focused to treat the organ to includebut not restricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The EMED device can be internal relative to the body andbelow the surface of the skin (6,90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs.blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. The EMED device(75,80) can lie on or near the surface of the parathyroid in order totreat the parathyroid 30. The EMED device 75 can puncture theparathyroid 30 to treat the parathyroid or it can enter a body part thatis a hollow organ or orifice or a combination of these body parts. TheEMED device can lie on or near the surface of a parathyroid artery orvein in order to treat the parathyroid 30. The EMED device can puncturea parathyroid artery or vein in order to ablate the parathyroidblood-flow. The EMED device can fully or partially ablate theparathyroid 30 The EMED device can fully or partially ablate the arteryor veins or nerves to the parathyroid or damage the local tissue in andnear the parathyroid 30.

In another embodiment the EMED device 80 can be on the skin. The EMEDdevice can be external and separated from the skin with or without amembrane or substance that bridges the EMED and the skin.

In one embodiment the ablation can be performed using a laser device.The laser device can be a Laser (Hot or Cold or Intermediate) Device.

In one embodiment the treatment can be performed by a laser utilizingparathyroid imaging including an internal device 75 or an externaldevice 80 that can include but is not restricted to ultrasound devicedirected to identify the hyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an laser treatment device in which the energy is directed into thebody utilizing imaging that can include but is not restricted toultrasound and the laser energy is focused to treat the organ to includebut not restricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The laser device can be internal relative to the body andbelow the surface of the skin (6, 90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs,blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. The laser device75 can lie on or near the surface of the parathyroid in order to treatthe parathyroid 30. The laser device 75 can puncture the parathyroid 30to treat the parathyroid or it can enter a body part that is a holloworgan or orifice or a combination of these body parts. The laser devicecan lie on or near the surface of a parathyroid artery or vein in orderto treat the parathyroid 30. The laser device can puncture a parathyroidartery or vein in order to ablate the parathyroid blood-flow. The laserdevice can fully or partially ablate the parathyroid 30 The LASER devicecan fully or partially ablate the artery or veins or nerves to theparathyroid or damage the local tissue in and near the parathyroid 30.

In another embodiment the laser device 80 can be on the skin. The laserdevice can be external and separated from the skin with or without amembrane or substance that bridges the laser and the skin.

In one embodiment the ablation can be performed using amechanical/kinetic/vibrational energy (KME) device which can include butis not restricted to the use or production of heat 98 or cold 96 orbrownian or vibrational motion.

In one embodiment the treatment can be performed by (KME) utilizingparathyroid imaging including an internal device 75 or an externaldevice 5 that can include but is not restricted to ultrasound devicedirected to identify the hyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an KME treatment device in which the energy is directed into the bodyutilizing imaging that can include but is not restricted to ultrasoundand the KME energy is focused to treat the organ to include but notrestricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The KME device can be internal relative to the body and belowthe surface of the skin (6,90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs,blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. The KME device 75can lie on or near the surface of the parathyroid in order to treat theparathyroid 30. The KME device 75 can puncture the parathyroid 30 totreat the parathyroid or it can enter a body part that is a hollow organor orifice or a combination of these body parts. The KME device can lieon or near the surface of a parathyroid artery or vein in order to treatthe parathyroid 30. The KME device can puncture a parathyroid artery orvein in order to ablate the parathyroid blood-flow. The KME device canfully or partially ablate the parathyroid 30 The KME device can fully orpartially ablate the artery or veins or nerves to the parathyroid ordamage the local tissue in and near the parathyroid 30.

In another embodiment the KME device 80 can be on the skin. The KMEdevice 80 can be external and separated from the skin with or without amembrane or substance that bridges the KME and the skin.

In one embodiment the ablation can be performed using a Thermal devicewhich can be a heating energy device. In one embodiment the method oftherapy is to cauterize the parathyroid and/or the parathyroid feedingarteries.

In one embodiment the treatment can be performed by heating or warmingutilizing parathyroid imaging including an internal device 75 or anexternal device 5 that can include but is not restricted to ultrasounddevice directed to identify the hyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an heating treatment device in which the energy is directed into thebody utilizing imaging that can include but is not restricted toultrasound and the heating energy is focused to treat the organ toinclude but not restricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The heating device can be internal relative to the body andbelow the surface of the skin (6,90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs,blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. The heating devicecan lie on or near the surface of the parathyroid in order to treat theparathyroid 30. The heating device 75 can puncture the parathyroid 30 totreat the parathyroid or it can enter a body part that is a hollow organor orifice or a combination of these body parts. The heating device canlie on or near the surface of a parathyroid artery or vein in order totreat the parathyroid 30. The heating device can puncture a parathyroidartery or vein in order to ablate the parathyroid blood-flow. Theheating device can fully or partially ablate the parathyroid 30 Theheating device can fully or partially ablate the artery or veins ornerves to the parathyroid or damage the local tissue in and near theparathyroid 30.

In another embodiment the heating device can be on the skin. The heatingdevice can be external and separated from the skin with or without amembrane or substance that bridges the HEATING and the skin.

In one embodiment the treatment can be performed using a thermal deviceto include a cooling/freezing device.

In one embodiment the treatment can be performed by a cryotherapy orcooling/freezing device utilizing parathyroid imaging including aninternal device 75 or an external device 80 that can include but is notrestricted to ultrasound device directed to identify thehyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto a cooling/freezing treatment device in which the energy is directedinto the body utilizing imaging that can include but is not restrictedto ultrasound and the cooling/freezing energy is focused to treat theorgan to include but not restricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using a internal device75. The cooling/freezing device can be internal relative to the body andbelow the surface of the skin (6,90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs,blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. Thecooling/freezing device can lie on or near the surface of theparathyroid in order to treat the parathyroid 30. The cooling/freezingdevice 75 can puncture the parathyroid 30 to treat the parathyroid or itcan enter a body part that is a hollow organ or orifice or a combinationof these body parts. The cooling/freezing device can lie on or near thesurface of a parathyroid artery or vein in order to treat theparathyroid 30. the cooling/freezing device can puncture a parathyroidartery or vein in order to ablate the parathyroid blood-flow. Thecooling/freezing device can fully or partially ablate the parathyroid 30the cooling/freezing device can fully or partially ablate the artery orveins or nerves to the parathyroid or damage the local tissue in andnear the parathyroid 30.

In another embodiment the cooling/freezing device can be on the skin.The cooling/freezing device can be external and separated from the skinwith or without a membrane or substance that bridges thecooling/freezing and the skin (6,90).

In one embodiment the treatment can be performed by a mechanicalablation device utilizing parathyroid imaging including an internaldevice or an external device that can include but is not restricted toultrasound device directed to identify the hyper-functioning parathyroidgland 30.

In one embodiment the treatment device can include but is not restrictedto an mechanical ablation treatment device in which the energy isdirected into the body utilizing imaging that can include but is notrestricted to ultrasound and the mechanical ablation energy is focusedto treat the organ to include but not restricted to the parathyroidgland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The mechanical ablation device can be internal relative tothe body and below the surface of the skin (6,90) and within the bodyparts that can include but is not restricted to subcutaneous tissue,hollow organs, blood vessels, orifices and other body parts or acombination of these body parts that provide access to the parathyroid30. The mechanical ablation device can lie on or near the surface of theparathyroid in order to treat the parathyroid 30. The mechanicalablation device 75 can puncture the parathyroid 30 to treat theparathyroid or it can enter a body part that is a hollow organ ororifice or a combination of these body parts. The mechanical ablationdevice can lie on or near the surface of a parathyroid artery or vein inorder to treat the parathyroid 30. The mechanical ablation device canpuncture a parathyroid artery or vein in order to ablate the parathyroidblood-flow. The mechanical ablation device can fully or partially ablatethe parathyroid 30 the mechanical ablation device can fully or partiallyablate the artery or veins or nerves to the parathyroid or damage thelocal tissue in and near the parathyroid 30.

In another embodiment the mechanical ablation device can be on the skin.The mechanical ablation device can be external and separated from theskin with or without a membrane or substance that bridges the mechanicalablation and the skin (6,90).

The mechanical ablation device can be formed such that the majority ofsharp or cutting edges are enclosed and that only a small element oraspect of the cutting surface is exposed this can include but is notrestricted to a tube with a side hole where the mechanical ablationoccurs. The mechanical ablation can include blades, cutting elements toinclude but not restricted to diamonds or other gems or stones, othersolids liquids or gasses. These ablative tools can be performing theirtask under equal, greater or less pressure than the body's internalpressure.

Parathyroid ablation can be directed at the parathyroid tissue, at thelocal tissue, to the nerves or at or to the parathyroid feeding vessels,including but not restricted to the parathyroid tissue, arteries andveins.

In one embodiment the ablation can be performed using a radioactivesubstance/radioactive seeds device.

In one embodiment the treatment can be performed using a radioactivesubstance including but not restricted to radioactive seeds device(63,64,65).

In one embodiment the treatment can be performed by a radioactivesubstance including but not restricted to radioactive seeds deviceutilizing parathyroid imaging including an internal device or anexternal device that can include but is not restricted to ultrasounddevice directed to identify the hyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an radioactive substance including but not restricted to radioactiveseeds treatment device in which the energy is directed into the bodyutilizing imaging that can include but is not restricted to ultrasoundand the radioactive substance including but not restricted toradioactive seeds energy is focused to treat the organ to include butnot restricted to the parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The radioactive substance including but not restricted toradioactive seeds device can be internal relative to the body and belowthe surface of the skin (6,90) and within the body parts that caninclude but is not restricted to subcutaneous tissue, hollow organs,blood vessels, orifices and other body parts or a combination of thesebody parts that provide access to the parathyroid 30. The radioactivesubstance including but not restricted to radioactive seeds device canlie on or near the surface of the parathyroid in order to treat theparathyroid 30. The radioactive substance including but not restrictedto radioactive seeds device 75 can puncture the parathyroid 30 to treatthe parathyroid or it can enter a body part that is a hollow organ ororifice or a combination of these body parts. The radioactive substanceincluding but not restricted to radioactive seeds device can lie on ornear the surface of a parathyroid artery or vein in order to treat theparathyroid 30. The radioactive substance including but not restrictedto radioactive seeds device can puncture a parathyroid artery or vein inorder to ablate the parathyroid blood-flow. The radioactive substanceincluding but not restricted to radioactive seeds device can fully orpartially ablate the parathyroid 30 the radioactive substance includingbut not restricted to radioactive seeds device can fully or partiallyablate the artery or veins or nerves to the parathyroid or damage thelocal tissue in and near the parathyroid 30.

In another embodiment the radioactive substance including but notrestricted to radioactive seeds device can be on the skin. Theradioactive substance including but not restricted to radioactive seedsdevice can be external and separated from the skin with or without amembrane or substance that bridges the radioactive substance includingbut not restricted to radioactive seeds and the skin (6,90).

In one embodiment the ablation can be performed using a laproscopicremoval system device, which can include but is not restricted tolaparoscopic surgery. The laparoscopic system can utilize but is notrestricted to an led to light the field and fiber-optic viewing,fiber-optic lighting and viewing simultaneously, a tube or channelplaced percutaneously.

In one embodiment the treatment can be performed using a laparoscopicremoval system device.

In one embodiment the treatment can be performed by using a laparoscopicremoval system device, utilizing parathyroid imaging including aninternal device or an external device that can include but is notrestricted to ultrasound device directed to identify thehyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an laparoscopic removal system treatment device in which the energyis directed into the body utilizing imaging that can include but is notrestricted to ultrasound and the laparoscopic removal system energy isfocused to treat the organ to include but not restricted to theparathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice. The laparoscopic removal system device can be internal relativeto the body and below the surface of the skin 6 and within the bodyparts that can include but is not restricted to subcutaneous tissue,hollow organs, blood vessels, orifices and other body parts or acombination of these body parts that provide access to the parathyroid30. The laparoscopic removal system device can lie on or near thesurface of the parathyroid in order to treat the parathyroid 30. Thelaparoscopic removal system device can puncture the parathyroid 30 totreat the parathyroid or it can enter a body part that is a hollow organor orifice or a combination of these body parts. The laparoscopicremoval system device can lie on or near the surface of a parathyroidartery or vein in order to treat the parathyroid 30. The laparoscopicremoval system device can puncture a parathyroid artery or vein in orderto ablate the parathyroid blood-flow. The laparoscopic removal systemdevice can fully or partially ablate the parathyroid 30 the laparoscopicremoval system device can fully or partially ablate the artery or veinsor nerves to the parathyroid or damage the local tissue in and near theparathyroid 30.

In another embodiment the laparoscopic removal system device can be onthe skin. The laparoscopic removal system device can be external andseparated from the skin with or without a membrane or substance thatbridges the laparoscopic removal system and the skin 6,90.

In one embodiment the treatment can be performed using apressure/suction ablation system device.

In one embodiment a pressure device is constructed to create negativepressure on the parathyroid gland 30. This negative pressure reduces thevenous 34 outflow from the parathyroid gland 30 and increases thecapillary bed pressure and decreases arterial 32 inflow. As a result,the parathyroid tissue 30 will undergo necrosis from a loss of arterial32 inflow and tissue edema and loss of venous 34 outflow, which createscell death and necrosis.

In another embodiment a pressure device is constructed to createpositive pressure on the parathyroid gland 30. This positive pressurereduces the venous 34 outflow from the parathyroid gland 30 andincreases the capillary bed pressure and decreases arterial 32 inflow.As a result, the parathyroid tissue 30 will undergo necrosis from a lossof arterial 32 inflow and tissue edema and loss of venous 34 outflow,which creates cell death and necrosis.

In one embodiment the treatment can be performed by a pressure/suctionablation system device utilizing parathyroid imaging including aninternal device or an external device that can include but is notrestricted to ultrasound device directed to identify thehyper-functioning parathyroid gland 30.

In one embodiment the treatment device can include but is not restrictedto an pressure/suction ablation system treatment device in which theenergy is directed into the body utilizing imaging that can include butis not restricted to ultrasound and the pressure/suction ablation systemenergy is focused to treat the organ to include but not restricted tothe parathyroid gland 30.

In one embodiment the treatment can be performed using an internaldevice 75. The pressure/suction ablation system device can be internalrelative to the body and below the surface of the skin 6, 90 and withinthe body parts that can include but is not restricted to subcutaneoustissue, hollow organs, blood vessels, orifices and other body parts or acombination of these body parts that provide access to the parathyroid30. The pressure/suction ablation system device can lie on or near thesurface of the parathyroid in order to treat the parathyroid 30. Thepressure/suction ablation system device 75 can puncture the parathyroid30 to treat the parathyroid or it can enter a body part that is a holloworgan or orifice or a combination of these body parts. Thepressure/suction ablation system device can lie on or near the surfaceof a parathyroid artery or vein in order to treat the parathyroid 30.the pressure/suction ablation system device can puncture a parathyroidartery or vein in order to ablate the parathyroid blood-flow. Thepressure/suction ablation system device can fully or partially ablatethe parathyroid 30 the pressure/suction ablation system device can fullyor partially ablate the artery or veins or nerves to the parathyroid ordamage the local tissue in and near the parathyroid 30.

In another embodiment the pressure/suction ablation system device can beon the skin. The pressure/suction ablation system device can be externaland separated from the skin with or without a membrane or substance thatbridges the pressure/suction ablation system and the skin 6.

In one embodiment, the coordination of robotic surgery with the abovetechniques and imaging can be combined.

In another embodiment, a method for treatment of the parathyroid glandcan include implanting a substance into the parathyroid gland 30 whichcan include but not restricted to a ferromagnetic substance which whenstimulated by an outside energy source to include but not restricted tomagnetic resonance ultrasound, electromagnetic energy, which can beexternal to the skin 6 or percutaneous. The substance in the preferredembodiment can create heat and cauterize the injected tissue

The primary substance can also be non-active in its primary state butwhen exposed to an outside energy source is activated either by anorganic or non organic reaction which can include but is not restrictedto forming a new compound or creating energy within the parathyroidgland 30 that can include but is not restricted to heat or a mechanicalablative process such as gyration or vibration. The energy source,activating compound, the primary substance or any combination of theabove can be delivered external to the skin 6. The energy source can bedelivered internal to the skin 92 within the body. The delivery caninclude but is not restricted to percutaneous.

In another embodiment a nanotechnology device can be implanted into theparathyroid gland 30 that can perform the treatment of the parathyroidgland 30 and can be used in combination with but not restricted to RadioFrequency Ablation Device (RFAD) Ultrasound High Frequency, Ultrasound(HIFU) Device, Electromagnetic Energy/Wave Delivery Device, Laser (Hotor Cold or Intermediate) Device, Mechanical/kinetic Energy/VibrationDevice, Heating Energy/Cauterizing Device, Cooling/Freezing Device,Medication, Sclerosing Device.

In another embodiment to protect the local tissue an introducer 50 forthe guidance or delivery system can be composed of material thatinsulates the surrounding tissue from the treatment agent to include butnot restricted to insulation of the surrounding tissue from RadioFrequency Ablation Device (RF, RFAD), Ultrasound High FrequencyUltrasound (HIFU) Device, Electromagnetic Energy/Wave Delivery Device,Laser (Hot or Cold or Intermediate) Device, Mechanical/kineticEnergy/Vibration Device, Heating Energy/Cauterizing Device,Cooling/Freezing Device, Medication and Sclerosing Device.

In another embodiment the treatment system can be combined with aguidance system to include but not restricted to: Ultrasound,Computerized Tomography (CT), Magnetic Resonance Imaging (MR/MRI), X-rayand other Electromagnetic Energy imaging methods to include but notrestricted to: Ultraviolet and Infrared, Thermography/Heat Detection,Blood Flow detection devices, Positron Emission Tomography, NuclearMedicine Imaging, Magnetic Imaging, Or a combination of any of thelisted methods.

In another embodiment, prior to the parathyroid treatment a percutaneousbiopsy can be performed. The introducer 50 can be used to facilitate thebiopsy such that the biopsy and ablation are all performed through theintroducer 50 or channels (54, 56).

In another embodiment, an Abnormal Parathyroid Gland 30 can be detectedwhen it has a rich blood supply and with this produces greaterproportional heat, which can be measured with a thermographic imagedetector.

In another embodiment, an Abnormal Parathyroid Gland 30 can be detectedwhen it has a rich blood supply and utilizes a greater proportionateoxygen, which can be measured with a O2 image detector.

In another embodiment, an Abnormal Parathyroid Gland 30 can be detectedwhen it has a rich blood supply and with this produces and because ofthis produce an orange color greater than local tissue.

In another embodiment, an Abnormal Parathyroid Gland 30 can be detectedwhen it has a rich blood supply and the greater blood flow and colorDoppler flow signals than local tissue.

In another embodiment, an Abnormal Parathyroid Gland 30 has a lower echotexture than local tissue and can have a well defined capsule andincreased blood flow and this pattern can be used to identify theparathyroid during ablation and treatment of the parathyroid.

The methods of treatment can be used alone or in multiple combinationsand can apply to multiple biological structures and tissue to includebut not restricted to the parathyroid gland 30 and parathyroid tissue30. In one example, a method of combination can include but is notrestricted to the use of negative pressure/suction to alter theparathyroids blood flow using a pressure device 75. In this examplenegative pressure is utilized which will alter the blood flow to theparathyroid gland 30. This will make the parathyroid tissue 30 moresusceptible to cell damage or cell death. In this example, a secondmethod of treatment can include but is not restricted to a cold laserdelivery device 75. By combining the negative pressure to theparathyroid gland 30 and the cold laser to the parathyroid tissue 30 thetime for effective ablation can be significantly reduced. This willspare the local tissue from any collateral damage that may be caused bythe use of the cold laser.

The trachea lies adjacent to and posterior to the thyroid 20 and the twoparathyroid glands 30. The Recurrent Laryngeal Nerve 13, whichinnervated the Larynx can be monitored or protected from the ablativeenergetic or non-energetic methods (not shown). Nerves can either betreated such as the parathyroid nerves 19 or protected such as theRecurrent Laryngeal Nerve 13.

In one embodiment a monitoring device 31 is used to protect afferent orefferent nerves 19 or structure innervated or in association with thenerve 19. The monitoring device 31 can be placed on or near a nerve 19,or on or near the structure 17 innervated or associated with the nerve19. In one embodiment, the monitoring device 31 can be used but notrestricted to parathyroid gland 30 and can involve but not restricted tomonitoring of the recurrent laryngeal nerve 13 and the larynx 15. Themonitoring device can measure but is not restricted to the measurementof either the parathyroid gland 30, local tissue environment or thenerve 19 or the structure associated with or innervated by the nerve ora combination of the above, and the monitoring can include but is notrestricted to the monitoring of heat, cold, acid or base pH,electromagnetic energy or kinetic energy. The monitoring device 31 canautomatically control the treatment delivery device 75 or can inform theuser of the treatment delivery device 75 that an action needs to betaken to avoid damage to vital structures. The monitoring device 31 canbe used to insure adequate treatment but also to avoid excessive damageto the structure or structures being monitored and can regulate thetreatment delivery device 75.

In another embodiment the monitoring device 31 can be used to monitorthe effectiveness of treatment of the target organ to include but notrestricted to the parathyroid 30. The monitoring device can measure butis not restricted to the measurement of either the parathyroid gland 30,local tissue environment or the nerve 19 or the structure associatedwith or innervated by the nerve or a combination of the above, and themonitoring can include but is not restricted to the monitoring of heat,cold, acid or base pH, electromagnetic energy or kinetic energy. Themonitoring device 31 can automatically control the treatment deliverydevice 75 or can inform the user of the treatment delivery device 75that an action needs to be taken to avoid damage to vital structures.The monitoring device 31 can be used to insure adequate treatment butalso to avoid excessive damage to the structure or structures beingmonitored and can regulate the treatment delivery device 75.

A method for localizing the parathyroid gland for a treatment to but notrestricted to surgical removal of the target tissue to include but notrestricted to parathyroid tissue 30. A needle/tube (52, 58, 70, 84),sheath 50, or device (75, 24) can be used to localize the site of thetarget organ to include but not restricted to the parathyroid gland 30.

In one embodiment, the method for localization can be using aradioactive tracer which can include but is not restricted toradioactive tecnecium Tc-99, or Iodine I-123, I-131. These isotopes canbe used in the unbound or bound for to include but not restricted totechnecium bound to a molecule to include but not restricted toSestamibi and albumin, or it can be bound to a solid or gel that caninclude but mot restricted to a biodegradable gel, surgical colloidal, aradioactive bead or clip or seed. The radioactivity can be placed withinthe body using a method that can reach the target organ to include butnot restricted to the parathyroid 30 which can include but notrestricted to percutaneous techniques, endoscopy, laparoscopy,catheterization and angiography. The radioactive isotope can beidentified using a localizing device (5, 75, 80), to include but notrestricted to a Geiger counter or radioactivity detecting probe whichcan direct therapy from or external to the skin to include but notrestricted to SPECT-CT, PET-CT, SPECT-MRI, ultrasound, surgery, orwithin the body to include but not restricted to a percutaneous device75 or a device that lies within the body by other means such as but notrestricted to endoscopy, laparoscopy, catheterization and angiography.The localizing substance 99 can be implanted or left in position priorto, during or after the procedure. The localizing substance 99 can beused to guide external, internal or any combination of external andinternal treatment modalities.

In another embodiment the localizing substance 99 can be a GlobalPositioning Satellite device, a Local Positioning Device (LPD) that canuse a specialty built localizing device for the treatment room and canmeasure distances in measuring quantities less than 1 cm.

In another embodiment the localizing substance 99 can be an inert,organic, non-organic, biodegradable or non-biodegradable device.

In another embodiment the localizing substance 99 can be a device thatcan externally or internally be monitored to local the target organ thatcan include but is not restricted to a GPS device, an LPD, and RFlocalization device.

In another embodiment the localizing device can be a wire or thread-likesubstance that can be straight and pass through tissue to include butnot restricted to the thyroid 20 or can be flexible and can bemaneuvered around tissue to include but not restricted to the thyroid20.

The localizing device and use any combination of localizing elements andmethods.

A method for treating the target organ can include but not restricted tothe parathyroid the method can deliver the treatment externally orinternally to include but is not restricted to percutanous laporascopicmethods or surgery.

Another method for treatment is to deliver an ablative substance to thetarget organ that can include but is not restricted to the parathyroid.The ablative substance or device can be inserted into the targetpreferentially by a needle percutaneously but also to include but notrestricted to by laproascope. The ablative substance or device caninclude but is not restricted to an RF receiver that can be implantedinto the target organ to include but not restricted to the parathyroid.

In another method microscopic ferrous particles can be inserted into theparathyroid and the neck 3 and parathyroid 30 placed into an MRI devicethat can heat and mechanically ablated the parathyroid tissue 30.

A needle for percutanuously depositing the localizing substance 99,which in the preferred embodiment can include a radioactivebiodegradable colloid with a titanium bead that measures less than 1 mm.The internal surface of the needle can include but is not restricted tothreads. The stylet 57 which fits into the hollow needle 58 can havemultiple shapes to include but not restricted to tips with points, blunttips, matching treads or grooves with the needle in which the stylet canbe screwed down into position. The stylet 57 and needle together canhave a delimiter or governor 55 that limits that adjusts to seat thelocalizing substance 99 into position within the parathyroid gland 30.

Other embodiments of this needle can include grooves to include but arenot restricted to horizontal or vertical grooves or threads or anycombination of grooves that can be locked and unlocked into place toseat and deliver the localizing substance 99 into the target organ.

Another embodiment includes a membrane inside of the needle on one orboth sides of the localizing substance 99, which can be pushed throughthe needle 58 and delivered to the target tissue to include but notrestricted to the parathyroid tissue 30.

In another embodiment the localizing substance 99 can be deposited intothe needle after the needle is secured to the target tissue 30 and oneor more stylets 57 can be used.

A sheath can include but is not restricted to a tube or conduit or guideor guide and it can be hollow

A member can include but is not restricted to a tube, cylinder, probewire, guide wire, guide, device and it can be solid or hollow.

Controller can include but is not restricted to a device that takes anaction in response to an input.

A measuring device can include but is not restricted to a sensor, or adevice to measure a quality or quantity of a substance or energy or aphenomenon or a biological event.

Biological function can include but is not restricted parathyroidhormone activity, temperature, calcium levels, ionizing calcium,electrolytes, local temperature around parathyroid, neuronal function(laryngeal nerves), larynx and innervation, respiratory function,sympathetic and parasympathetic (primary and secondary) function,arterial flow, venal flow, brain function, cardiac functions, bloodpressure, chromography, and vital and hormonal and physiologicmeasurements, signs and symptoms

A substance can include but is not restricted to solids or liquids orgels or plasmas or gases to include but not restricted to organic andinorganic materials such as but not restricted to medications,pharmaceuticals, adhesives, glues, metals, alloys, plastics,carbo-carbon fibers, oxygen, argon, nitrogen, carbon monoxide,ferromagnetic materials, alchohols, peptides, fats, proteins, nucleicacids, or carbohydrates.

Energy can refer to any form of energy, including various forms ofelectromagnetic energy, such as: radiofrequency (RF) energy; therapeuticultrasound energy; microwave, laser, x-ray, or optical energy;magnetism, head and cryrotherapy; or any combination thereof. Energyshall also refer to mechanical energy to include but not restricted toBrownian movement, heat, freezing, crotherapy, cutting, tearing,crushing, spinning, piercing, poking prodding, dividing, removing andsegregating or any combination thereof. Energy can include an energyfrom a device to include but not restricted to an Electromagnetic device(EMD) which can include but is not restricted to Radiofrequency ablation(RF) and microwave (MW) and laser (L), Cryotherapy (CryT), HightIntensity Focused Ultrasound (HIFU), Radioactive Therapy (Brachytherapy:BrT), Irreversible Electroporation (IRE), Electrical Current Therapies,Electrocautery, Magnetic Resonance (MR), Ultrasound, (US), Thermalenergies both heat and cold or can include but is not restricted toforces such but not restricted to suction, positive and negativepressure, or forces or not exerted by a vacuum.

Placement of the needle can include but is not restricted to placementby at least one organism with or without robotic assistance.

Treatment and Insulation and protection of the target and non-targetvicinity tissue can include the delivery and the removal of energyand/or substances.

The energy delivered and the insulation experienced at any given momentduring treatment by the user's target and non-target tissue can bothvary and can be variable to include but not restricted to duration,direction, exposure, periodicity or frequency.

The following methods and devices and applications can be applied toHumans or Non-human.

While the preferred embodiment of the invention has been illustrated anddescribed, as noted above, many changes can be made without departingfrom the spirit and scope of the invention. Accordingly, the scope ofthe invention is not limited by the disclosure of the preferredembodiment. Instead, the invention should be determined entirely byreference to the claims that follow.

1. A method for treating a target tissue, comprising: locating thetarget tissue within a patient's body, the target tissue having aperimeter and surrounding non-target tissue; positioning a deliverydevice relative to the target tissue such that the delivery device isconfigured to deliver to the target tissue within the perimeter apredetermined quantity of at least one of energy or substance sufficientto control a hormonal function of the target tissue without deliveringthe predetermined quantity of the at least one of energy or substance tothe surrounding non-target tissue; and delivering the predeterminedquantity of at least one of energy or substance to the target tissue. 2.The method of claim 1, further comprising: positioning an insulationdevice relative to the surrounding non-target tissue; and insulating thesurrounding non-target tissue to prevent the at least one of energy orsubstance delivered to the surrounding non-target tissue from exceedingthe predetermined quantity.
 3. The method of claim 1, wherein the energycomprises at least one of electromagnetic energy, kinetic energy,vibrational or mechanical energy, thermal energy, cryotherapy,hyperthermia, radiofrequency (RF) energy, microwave energy, infraredradiation (IR), visible light, ultraviolet radiation, x-ray, gamma ray,radioactive energy, brachytherapy, electric current, irreversibleelectroporation, electrocautery, ultrasound energy, high intensityfocused ultrasound energy (HIFU), magnetic energy or forces, a vacuum,positive and negative pressure energy or forces.
 4. The method of claim1, wherein the substance includes one or more of solids, liquids, gels,plasmas, or gases.
 5. The method of claim 1, wherein the target tissuecomprises a parathyroid gland and the non-target tissue comprises atleast a laryngeal nerve or a vagus nerve.
 6. The method of claim 1,wherein positioning the delivery device relative to the target tissuecomprises: inserting at least one of a percutaneous member, asubcutaneous member, or a conduit into the patient's body; andtransmitting the at least one of energy or substance percutaneously orthrough an incision.
 7. The method of claim 1, wherein positioning thedelivery device relative to the target tissue comprises: inserting atleast one of a percutaneous member, a subcutaneous member, or a conduitinto the patient's body; and transmitting the at least one of energy orsubstance non percutaneously, laproscopically, angiographically,endoscopically, or transcutaneously.
 8. The method of claim 1, wherein:the delivery device has a delivery surface area from which the at leastone of energy or substance is delivered; and positioning the deliverydevice comprises positioning the delivery surface area completely withinthe perimeter of the target tissue.
 9. The method of claim 1 furthercomprising measuring the at least one of energy or substance deliveredto at least one of the target tissue and the surrounding non-targettissue.
 10. The method of claim 9, further comprising controlling theamount of at least one of energy or substance delivered to at least oneof the target tissue and the surrounding non-target tissue in responseto the measured at least one energy or substance delivered.
 11. Themethod of claim 10, further comprising maintaining a temperature of thesurrounding non-target tissue below a predetermined thresholdtemperature.
 12. The method of claim 1, wherein locating the targettissue comprises at least one of conducting a nuclear medicine study,using an ultrasound device, using a magnetic resonance imaging device,using a computed tomography device, or using a thermography device. 13.The method of claim 1, wherein positioning the delivery device relativeto the target tissue comprises inserting a portion of the deliverydevice into the target tissue.
 14. The method of claim 1, furthercomprising monitoring at least one physical characteristic of thepatient as the at least one of energy or substance is applied to thetarget tissue, wherein the physical characteristic comprises at leastone of parathyroid hormone activity, temperature, calcium levels,ionizing calcium, electrolytes, local temperature around the targettissue, nervous function, characteristics of the larynx and associatedinnervation, respiratory functions, sympathetic and parasympathetic(primary and secondary) function, arterial flow, venal flow, brainfunction, cardiac functions, blood pressure, chromography, and vital,hormonal, and physiologic measurements, signs and symptoms, andbiological functions.
 15. The method of claim 1, wherein the targettissue comprises a parathyroid gland and the surrounding non-targettissue comprises neural tissue.
 16. A device for delivering at least oneof energy or substance to a target tissue within a patient's body andfor insulating surrounding non-target tissue from contact with theenergy or substance, the device comprising: a delivery device configuredto deliver a predetermined amount of at least one of energy or substanceto a target tissue within the patient's body; and an insulatorpositioned around at least a portion of the delivery device, wherein theinsulator is configured to insulate the surrounding non-target tissuefrom at least one of the energy or substance delivered by the deliverydevice.
 17. The device of claim 16, further comprising at least onemeasuring device configured to measure the at least one of energy orsubstance delivered to the target tissue near the target tissue.
 18. Thedelivery device of claim 17, further comprising a controller configuredto control the amount of at least one of energy or substance deliveredto the target tissues and to the non-target tissues in response to themeasured energy.
 19. The device of claim 18 wherein the insulatorcomprises one or more physical, substance, or energy inhibitor to atleast one of energy transmission or substance delivery.
 20. The deviceof claim 16, wherein the insulator is adjustable to vary at least one ofthe intensity, duration, direction, periodicity or frequency ofapplication of the at least one of energy or substance.
 21. The deviceof claim 16, wherein: the delivery device comprises an elongated memberor conduit having a proximal end and a distal end; and the insulatorcomprises a sheath or guide extending substantially along the deliverydevice between the proximal end to the distal end of the deliverydevice.
 22. The device of claim 16, wherein the device further comprisesa second insulator positioned between the insulator and non-targettissue to inhibit the at least one of energy or substance fromtransferring from the target tissue to the non-target tissue.
 23. Thedevice of claim 22, wherein the second insulator is positioned between aportion of the target tissue that receives a high concentration of theat least one of energy or substance from the delivery device.
 24. Thedevice of claim 16, wherein the delivery device is configured to deliverenergy in the form of at least one of electromagnetic energy, kineticenergy, vibrational or mechanical energy, thermal energy, cryotherapy,hyperthermia, radiofrequency (RF) energy, microwave energy, infraredradiation (IR), visible light, ultraviolet radiation, x-ray, gamma ray,radioactive energy, brachytherapy, electric current, irreversibleelectroporation, electrocautery, ultrasound energy, high intensityfocused ultrasound energy and/or substance (HIFU), magnetic energyand/or substance or forces, a vacuum, and positive and negative pressureenergy and/or substance or forces.
 25. The device of claim 16, wherein:the delivery device has a delivery area from which the at least one ofenergy or substance is delivered; and the delivery area is smaller thanthe target tissue.
 26. The device of claim 25, wherein the delivery areais positioned to contact a sufficiently small quantity of the non-targettissue such that functionality of the non-target tissue is substantiallynot affected.
 27. The device of claim 16, further comprising at leastone treatment-inhibiting energy and/or substance delivery conduit ormember configured to deliver at least one of treatment-inhibiting energyor substance to the non-target tissue.
 28. The device of claim 16,wherein the target tissue comprises parathyroid tissue.
 29. The deviceof claim 16 wherein the predetermined amount of at least one of energyor substance is sufficient to control hormonal control of the targettissue.
 30. A method of treating a target tissue without substantiallytreating surrounding non-target tissue, the method comprising:positioning a delivery device into operable proximity with the targettissue of a patient's body; delivering at least one of energy orsubstance to the target tissue through the delivery device sufficientlyto at least partially accomplish at least one of modulate, activate,deactivate, neutralize, partially ablate, fully ablate, damage, ormodify the target tissue; monitoring the quantity of the at least one ofenergy or substance at the target tissue and surrounding non-targettissue; and adjusting the amount of the at least one of energy orsubstance delivered through the delivery device to maintain the energyor substance delivered to the target tissue within a treatment range inwhich the treatment is modulated, activated, deactivated, neutralized,partially ablated, fully ablated, damaged, or modified and to maintainthe at least one of energy or substance delivered to the surroundingnon-target tissues outside the treatment range to maintain viability ofcritical non-target tissue.
 31. The method of claim 30, wherein: thetreatment range is defined in terms of temperature; and the treatmentrange includes 5 degrees C. and below and 46 degrees C. and above. 32.The method of claim 30, further comprising: monitoring a biologicalcharacteristic of the patient; and controlling the amount of the atleast one of energy or substance applied through the delivery device asa function of the biological characteristic.
 33. The method of claim 32,wherein the biological characteristic comprises at least one ofparathyroid hormone activity, temperature, calcium levels, ionizingcalcium, electrolytes, local temperature around the target tissue,nervous function, characteristics of the larynx and associatedinnervation, respiratory functions, sympathetic and parasympathetic(primary and secondary) function, arterial flow, venal flow, brainfunction, cardiac functions, blood pressure, chromography, vital,hormonal, and physiologic measurements, signs and symptoms, andbiological functions.
 34. The method of claim 30, further comprisinginsulating the surrounding non-target tissue to prevent the at least oneof energy or substance delivered to the surrounding non-target tissuefrom exceeding a predetermined threshold limit.
 35. The method of claim30, wherein the delivery device has a delivery area sizeable relative tothe target tissue such that delivering the at least one of energy orsubstance to the target tissue from the delivery area modulates thefunctionality of the target tissue and does not substantially affectsurrounding non-target tissues.
 36. The method of claim 30, furthercomprising controlling biological functions of the target tissues byapplying the at least one of energy or substance to the target tissue.37. The method of claim 30, further comprising at least one ofmodulating, activating, deactivating, neutralizing, partially ablating,or fully ablating at least a portion of the target tissue withoutmodulating, activating, deactivating, neutralizing, partially ablating,or fully ablating any significant portion of the non-target tissue. 39.The method of claim 30 wherein delivering at least one of energy orsubstance comprises controlling hormonal function of the target tissue.40. The method of claim 30 wherein the target tissue comprisesparathyroid tissue